chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain with tenderness of the left arm; redness in the left arm; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 8-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of erythema (received for several seasons). Concomitant products included ibuprofen, paracetamol (Tylenol) and benadryl (nos) (Benadryl).   On 10th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season. On 10th October 2020, less than a day after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced pain in arm. In October 2020, the patient experienced erythema. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the erythema was recovered/resolved.   It was unknown if the reporter considered the pain in arm and erythema to be related to Fluarix Quadrivalent 2020-2021 season.   Additional details were provided as follows: The reporter stated that the patient has received flu vaccine in past seasons (several years).  The patient received Fluarix Quadrivalent 2020-2021 season and experienced pain with tenderness of the left arm, about 24 hours after experienced redness in the left arm from the accromium to the elbow and was tensed and unhappy when vaccine was administered. The redness was resolved in 72 hours. The patient was treated with Tylenol, ibuprofen, and Benadryl. The reporter contacted the patient's primary doctor via phone or text and primary doctor did not advise that the patient avoid future flu vaccinations based on this reaction. The reporter consented to follow up. This case was linked with case US2020AMR206466 and US2020AMR206465 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR206466:same reporter US-GLAXOSMITHKLINE-US2020AMR206465:same reporter
first dose of Moderna COVID19 vaccine 03feb2021 and is scheduled for the second dose  tomorrow, 23mar2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID19 vaccine 03feb2021 and is scheduled for the second dose  tomorrow, 23mar2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ULUMZ(U/O)A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID19 vaccine 03feb2021 and is scheduled for the second dose  tomorrow, 23mar2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID19 vaccine 03feb2021 and is scheduled for the second dose  tomorrow, 23mar2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported. No relevant concomitant medications were reported.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: ULUMZ(U/O)A) with no associated AEs.
1ST DOSE PFIZER VACCINE REACTION:   April 6:  Received first dose of Pfizer vaccine.    April 6-10:  Felt sick with mild flu-like symptoms. Better each day after that, and eventually back to normal.  April 23: 17 days after vaccine began to feel unwell.  April 24:  Face, neck, and chest were quite red, not feeling well.   April 25:  Woke up feeling awful, darker and deeper red from head to knees, face and neck puffy/swollen.  Exhausted, heavy eyes and head, slight wheeze at night.  Skin on face and neck slightly thickened, in some places, and warm to touch. Felt like heart was pounding, but don't think pulse was elevated.  Took Benadryl (3 tablets in 24 hours), antacid, and felt slightly better.    April 26:  Still red, but lighter shade.  Redness in face and body faded more with each day.  April 28:  Saw a dermatologist who suggested this was DRESS syndrome. Asked if lab tests were necessary/useful; he said not at this time.  May 1:  Looking pretty normal.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jun2021 as dose 2, single (Lot number: EW0191) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Patient received the Moderna manufacturer as a first dose. The Pfizer manufacturer was mistakenly given as the second dose.
Pain in the arm lasted longer than the first dose.  All of a sudden felt very fatigued, lethargic.  Only lasted 24 hours.  The next day felt normal again
Patient received both BOOSTRIX and FLUCELVAX on Monday 10/23/17 in her left arm. On Wednesday morning 10/25/17 the patient called are reported her arm was red at the injection site and the surounding area, it was swollen and there was a rash. She also reported experiencing headaches. The patient states the symptoms have progressively gotten worse since the injection.
About 5-6 hours after the second dose of the Moderna vaccine, Patient developed a rash that looked like hives/an allergic reaction. It started on his neck and spread widely over his body. He did not have any symptoms at all after the first Moderna dose 2 weeks prior. We called the pharmacy and they told us to give him Benadryl. They told us that he did not need to go to the ER since the reaction occurred more than 4 hours after the second dose was administered, and to watch for more severe symptoms like difficulty breathing and to go to the ER if that happened. Patient went to urgent care the next day since the rash did not go away and they recommended a double dose of a daily allergy pill, since it was time-released and would help the reaction more than Benadryl. The rash slowly went away after 3-4 days.
Started overnight (after 9:30pm on 3/23/21: Injection site pain,Tiredness,- The following occurred around 8am on 3/24/21: Headache,Muscle pain, Chills, Joint pain, Fever, Nausea, Feeling unwell, Dizziness, Fainting
Left shoulder pain, pain down left side. Broke out in blisters. Blisters continued and enlarged. Became absess of a lymphnode on left lower pelvis. Absess ruptured and bled for about a month and a half.  On April 7th received 2nd dose of the Pfizer Covid vaccine.  Impact blood component, Sed rate
no other adverse events/effects reported; improperly stored ROT ATEQ was administered yesterday; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-MAR-2021, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 milliliter, orally, lot # 1691303, expiration date 21-DEC-2021 (strength and dose were not reported) for prophylaxis.  On an unknown date, the dose of the vaccine was exposed to temperature excursion at 47.1 Fahrenheit degrees (F) for 10 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Patient came 6 days after getting injection complaining of right shoulder and arm pain with rash and swelling on injection site. Slight infection was seen on site of injections therefore was started on antibiotic course along with anti-inflammatory medication that would also aid with pain. Also prescribed mupirocin 2% topical ointment, advised to follow back if symptoms persist.
Left eye blurred vision - persistent, worse at the end of the day.  Difficulty focusing.  Also general overall fatigue.
pt passed out 30mins p/vax; taken to ER w/BP 174/90
Janssen COVID-19 Vaccine EUA Received Vaccine at 2pm on 3/23 Chills/ Shakes started at 11pm 3/23 until 3am 3/24 Fever/ Sweats/ Chills / Aches / Headache from 3am 3/24 until 7pm 3/24 Sweats overnight on 3/24 & 3/25
Information has been received from a physician concerning a 12 month old patient (gender not reported) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On an unspecified date (12 days post vaccination), the patient developed a "mild" case of chicken pox. The patient's status was not reported. Additional information has been requested.
DOS 12/20. Color change, warm temperature in area. (RT) deltoid. Erythema, itching. TX: Diphenhydramine.
RIGHT SIDE STOMACH PAIN WITH DEEP INSPIRATION; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient did not have any history of drug abuse or illicit drug use. No concomitant medication was used. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 07-MAR-2022) dose was not reported, administered on 11-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-NOV-2021, the patient experienced right side stomach pain with deep inspiration. On 11-NOV-2021, the patient experienced fever. On 11-NOV-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, nausea, and right side stomach pain with deep inspiration. This report was non-serious.
Information has been received from an 84 year old consumer who received an injection of flu shield on 11/12/2001. Four days following vaccination, on 11/16/2001, the pt experienced diarrhea, a low grade fever, and a runny nose.
Facial swelling in cheeks, lips, chin, beneath eyes started on L side of face, first noted upon waking in am after vaccine the previous day. Hx of dermal filler one year ago.
A report was received from a health care professional on 11/23/2002 concerning eleven vaccinees between the ages of 56-84 years who were inadvertently administered 1ml Fluvirin on and unreported date. On an unreported date eleven vaccines were inadvertently administered 1ml Fluvirin. No adverse reactions were reported. There was insufficient information to determine the reporteres cuasality assesment. Update1 12/31/2002: A follow up report was received from a health care professioanl indicated that a 56 year old female vaccinee was inadvertently administered 1.0ml  Fluvriin on 11/21/2002. Cross Reference with: PJP200200806, PJP200200906, PJP200200905, PJP200200904, PJP200200903, PJP200200902, PJP200200901, PJP200200900, PJP200200899, PJP200200898.
Since getting my second Covid shot I?ve notice an onset of tingling in my hands and feet.
Immediate headache after first injection, minor, lasted up to 48 hours. Sore arm at injection site for 2 days after first injection. About three weeks after second injection developed shortness of breath,  chest pain when inhaling especially during a run, no signs of improvement almost 60 days later.
Left arm was sore, itchy, red & warm Hard for patient to sleep. She iced it down occasionally which helped and the area is still a little red & slightly warm after 5 days
Lightheaded, nausea, ringing in ears. Evaluated by EMS-Cleared
Received flu shot earlier in day, later that night experienced severe pain in upper R deltoid, with myalgia and arthralgia. Had difficulty sleeping and noticed odd spots scattered on R arm. Thought that injection might have been administered too high in the deltoid.  Myalgia, Arthralgia, SkinRash, ErythemaMultiform & NA IBUPROFEN 800 mg PRN
Information regarding Flumist nasal solution was received from a healthcare professional regarding a patient who received a dose on an unspecified day and month in 2003. It was reported the patient experienced a bad taste in the back of their mouth for a short while and product ran back out of both nostrils. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered on an unspecified day and month in 2003. Dose regimen was 0.5mL 1 time per day (nasal). Concomitant medications were not reported. The patient experienced bad taste in mouth in 2003. The reporter indicated that 8-9 patients between the ages of 5-18, experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.  No additional information was available at the time of this report.
Pancreatitis. The major causes of pancreatitis were ruled out in my case. after thorough testing
I received the flu shot in my upper left arm and within 1 week - I developed pain and discomfort at the injection site.  Since then the pain has been persistent and the pain is now radiated down past my elbow and into my forearm
by the next morning, i had a scratchy throat, watery eyes.  by the afternoon, i had body aches and tiredness.  by the time i got home from work, my heart was racing.  laid down and by evening, was nauseated and congested in nose along with the other symptoms.  By the next morning, the scratchy throat was gone, intense body aches, heart was still racing and very stuffy nose
got vaccine - about a week later - she sent us a message saying "I have been having right calf pain for about a week or more. I have more increased SOB and chest pain." was able to get ddimer which was elevated - and was admitted to the hospital for this  since her vaccine - she has noticed increased chest tightness, SOB, hairloss, DVT/PE.
Patient became very sluggish and a little disoriented. Blood pressure was severly low. Patient was monitored in urgent care.  EMS was called. Patient refused treatment
SEVERE PAIN FROM SHOT SITE TO TIPS OF FINGERS LIKE SOMETHING BREAKING AND RIPPING THROUGH MY ARM RIGHT AFTER VACCINE GIVEN FOR AN HOUR, SLIGHT STIFFNESS IN NECK WITH LEFT ARM SORE (GIVEN 2ND VACCINE IN RIGHT) SORENESS GOES AWAY FOR 4-5DAYS THEN LEFT ARM IS PAINFUL WITH PRESSURE APPLIED AT TOP OF ARM 2 DAYS LATER HEADACHES BEGAN AGAIN. SINCE FIRST ROUND OF VACCINE GIVEN I HAVE HAD WEAKNESS, LIGHTHEADEDNESS, HEADACHES, NAUSEA, AND FATIGUE USUALLY AFTER A COUPLE HOURS AFTER BEING AWAKE. SHOULDER MUSCLE IN NECK IS ALSO CONSTANTLY TIGHT AND PAINFUL. I DID NOT HAVE THESE SYMPTOMS BEFORE I STARTED THIS SERIES OF VACCINATIONS. I CONTINUED TAKING THE MEDS I WAS GIVEN FROM THE FIRST TIME BECAUSE THE DOCTORS DID NOT BELIEVE ME WHEN I WENT IN ON 3/3/07 AND 3/5/07. I STILL HAVE PAIN WHERE I HAVE TO TAKE MEDICINE FOR IT DAILY.
began w/t012a-105 a placed in tub of cool H20 & temp dec 102 APAP given;830PM sz, shaking, stiff, unresponsive, turned blue-1min;amb came in 1-2min & taken to hosp;EKG, CXR, blood, urine all neg;strep test;tired p/home
Running back and forth all day; Stomach hurts; Product administered to patient of inappropriate age (16 years old); This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOMOTOR HYPERACTIVITY (Running back and forth all day), ABDOMINAL PAIN UPPER (Stomach hurts) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to patient of inappropriate age (16 years old)) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included ADHD.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PSYCHOMOTOR HYPERACTIVITY (Running back and forth all day), ABDOMINAL PAIN UPPER (Stomach hurts) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to patient of inappropriate age (16 years old)). At the time of the report, PSYCHOMOTOR HYPERACTIVITY (Running back and forth all day) and ABDOMINAL PAIN UPPER (Stomach hurts) outcome was unknown and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to patient of inappropriate age (16 years old)) had resolved.            No concomitant drug details were reported.   Patient was running back in fourth all day and now he said stomach hurt.   No treatment details were reported.
FEVER OF 103; HOT; CHILLS AND SHIVERING; SHAKING; FREEZING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  On 20-MAR-2021 the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry date: unknown) dose was not reported, frequency 1 total, in left deltoid, for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, the patient experienced fever of 103, hot, chills, shivering. On same day, about 4 hours after receiving the vaccine she reported shaking and freezing, being very cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from chills, and shivering on 20-MAR-2021, and had not recovered from fever of 103, and hot. The outcome of the shaking and freezing was not reported. This report was non-serious.; Sender's Comments: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Redness, swelling below injection site. Chills 2nd day, tender to the touch
Pt received 4 vaccines and following the last one (MMR), the pt simultaneously, rolled her eyes back and experienced involuntary jerking of hands and arms. Child placed on floor with bilateral legs elevated above heart. Child opened her eyes. BP 88/52, R 70, pale and diaphoretic for 15 minutes with nausea but no emesis.
Information has been received from a physician concerning approximately 14 year old female who on unspecified date was vaccinated with the first dose of Gardasil and passed out, and needed stitches on her nose, because the bridge of her glasses cut her nose.  Subsequently, the patient recovered.  This is one of several reports received from the same source.  Additional information has been requested. 07/08/08 Follow-up information indicated request for no further contact. No additional information available.
Nausea, chills, headache, body ache, pain at the site of injection, fatigue
Vomiting x 1, diarrhea (slight), severe pain in legs, extreme weakness lasted 1 day, self-treated with aspirin, onset approximately 4 hours after.
I was noticing I developed an eye floater which was very large and noticeable. I also had ocular pressure like a headache. The floater was in the right eye. I went to the eye doctor, and she completed a test to check the eye pressure. The results show that the pressure was abnormally high. She did not have any specific cause or diagnosis. She gave me some drops to relieve the pressure. The symptoms are still kind of the same. I am also taking over the counter decongestant as it was also thought that it could be sinus pressure. I have a follow up appointment coming up.
missed my second appointment scheduled for May 21; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed my second appointment scheduled for May 21) 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 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed my second appointment scheduled for May 21). On 21-May-2021, PRODUCT DOSE OMISSION ISSUE (missed my second appointment scheduled for May 21) had resolved.            No concomitant medications were reported.   Reporter did not allow further contact
Hypovolemia, dehydration, acute renal injury d/t hypovolemiaLabs
Breakthrough case admission after three vaccines Pfizer 3/19/21 Lot# ER8727;  4/9/21 Pfizer EW0150;  Pfizer 12/3/21 Lot# FH8028
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: tip of tongue got numb after waiting for about 10 minutes after receiving the vaccine. she explained it like it feeling as though she drank hot coffee and burnt the tip of her tongue. she said she felt fine besides that and decided to leave.
Patient reported light headedness, shortness of breath, and itchy throat about 15 min after vaccine. Patient took 50 mg diphenhydramine PO, remained on site for about an hour, reported improvement in symptoms at that time and left.
Information has been received from a pharmacist via a company representative referring to a female patient of unknown age. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date in July 2015 (reported as "last month"), the patient was vaccinated with a dose of ZOSTAVAX (lot# L011534, expiration date and route were unknown). No concomitant medication was reported. On an unknown date the patient developed redness and swelling at the injection site. The patient sought medical attention via going to pharmacy on an unspecified date and reporting the event to the pharmacist. The outcome of injection site erythema and injection site swelling is unknown. The causality between the event and the ZOSTAVAX was not reported. Additional information has been requested.
VACCINE GIVEN >24 HOURS AFTER MDV PUNCTURED.  PT IS SCHEDULED TO BE RE-VACCINATED
Patient received shingles vaccine and approximately 5 weeks later starting to develop rashes that appear to be shingles.  Patient believes that vaccine to be the trigger.
He had severe taccardia, fever  chills nausea vomiting and diarrhea. I called the doctor who advised us to come to the ER. I took him to the ER the next morning where they gave fluids, did a cat scan, gave antibiotics. He was admitted to the hospital for observation and released the next afternoon.
Pfizer 4/7/21 and 4/28/21. Positive on 1/10/22