chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling; Experienced fever; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling) and PYREXIA (Experienced fever) in a female 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 recorded medical history).    On 07-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced SWELLING (swelling) and PYREXIA (Experienced fever). At the time of the report, SWELLING (swelling) and PYREXIA (Experienced fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
A nurse reported that a 35 year old pt received vaccine and developed fever and headache. Pt also developed large reaction to injection site characterized by redness, swelling and warmth, extending from shoulder to elbow.
bells palsy, given prednisone, symptoms of that went away after a couple of weeks   but I stared to develop tingling in both hands and feet and lips and tip of tongue. this is still present to this day. have had blood work stress test, ekg.
Day after vaccine pain to touch..After that there was a lump near the injection site.. Next day rash around the site and very itchy..Used Hydrocortisone cream for 2 days..I also took Advil for pain.Day after shot when I experienced pain..only took 2x in morning and evening..
SORE ARM; SLIGHT FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced sore arm. On 2021, the subject experienced slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight fever and sore arm was not reported. This report was non-serious.
I've been having DVT's (deep vein thrombosis) that I have not had before. But it could be connected to my pre-existing conditions and double lung transplant.
I got vaccine on Tuesday 03/16. First 6 hours, I felt very tired. After 6 hours, I started to feel nauseous, headache, fever, body ache, and shortness of breathe. These symptoms got severe after the next day that my temperature reached 102.9 F. This symptoms continued through the weekend too so I had to visit urgent care to get treated. I felt like my head was spinning and tilting to the right side. They measured my blood pressure and said that it is low due to possibly that my heart is not pumping enough blood to reach to my brain. I wanted to get blood test done, but they didn't let me. After a week, I don't have any symptoms other then sometimes having hard time breathing for 5 minutes.
33 year old female presents approx 48 hours after receiving 4th rabies vaccine. Patient states has had dizziness, abd cramping, nausea, and vomiting that has progressed over the past 46 hours.  Patient recieved 1000mlNS, Pepcid 20mg IV, Zofran 4mg IV, Prednisone 60mg IV
Little cramping and uncomfortable feeling only when urinating and felt burning at the end of the urination; Little tiny light pink in urine/After 30 minutes when urinate again it has little red; Pee more than the usual and this was just after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (Little cramping and uncomfortable feeling only when urinating and felt burning at the end of the urination), CHROMATURIA (Little tiny light pink in urine/After 30 minutes when urinate again it has little red) and POLLAKIURIA (Pee more than the usual and this was just after the vaccine) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE for an unknown indication.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced DYSURIA (Little cramping and uncomfortable feeling only when urinating and felt burning at the end of the urination), CHROMATURIA (Little tiny light pink in urine/After 30 minutes when urinate again it has little red) and POLLAKIURIA (Pee more than the usual and this was just after the vaccine). At the time of the report, DYSURIA (Little cramping and uncomfortable feeling only when urinating and felt burning at the end of the urination), CHROMATURIA (Little tiny light pink in urine/After 30 minutes when urinate again it has little red) and POLLAKIURIA (Pee more than the usual and this was just after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took Tylenol right after the vaacination, for unknown indication.
Per mom-states daughter developed hives 4 days after the injection on her neck and 5th day after also on her face, chest, back, arms-gave BENADRYL.
Rheumatoid arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4447026-00.  A 59-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered with sequelae", described as "Rheumatoid arthritis flare up". The action taken for adalimumab was unknown.  The reporter considered "rheumatoid arthritis flare up" related to BNT162b2. The reporter's causality for the event(s) of Rheumatoid arthritis flare up with Humira (Adalimumab) was a reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Moderna Covid-19 EUA symptoms-General swelling of entire body still ongoing, rash(new), numbness and tingling of arm were shot was administered lasting 24hrs, cluster headaches, fever for over 24hrs still ongoing
Initial unsolicited report received from nurse on 21-Sep-2018. This case is linked to cases 2018SA267265, 2018SA267253, 2018SA267282, 2018SA267283, 2018SA267295, 2018SA267294, 2018SA267293, 2018SA267304 and 2018SA267305. This case involves a [55 years old] female patient who was vaccinated with a single 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UI815AA, expiration date: 30-Jun-2018, site of administration: right deltoid and route was not reported) on 17-Sep-2018. The patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used. No reaction reported. 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. List of documents held by sender: none.
Approximately 5 min. after receiving vaccines, nurse returned to room and noticed child's face was flushed on further exam she noticed hives on arms, face and abdomen. Child was take to provider for evaluation. Provider stated child was having reaction. Order given to give epinephrine 1:1000, 0.15 cc SQ stat. Epinephrine given and symptoms started improving within a couple of minutes. Child observed for over 1/2 hour, symptoms completely resolved. Lungs remained clear. Child was discharged to home. Given instructions to got to ER if any problems.
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of LIQUID PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to a female patient vaccinated with improperly stored ROTATEQ oral; lot# N005618 with expiration date 04-OCT-2018) on 27-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter (link reports: 1710USA004069, 1805USA001661, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
lightheadedness; vertigo; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting), DIZZINESS (lightheadedness) and VERTIGO (vertigo) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting), DIZZINESS (lightheadedness) and VERTIGO (vertigo). The patient was treated with MECLIZINE [MECLOZINE] for Nausea, Vomiting, Lightheadedness and Vertigo, at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea), VOMITING (vomiting), DIZZINESS (lightheadedness) and VERTIGO (vertigo) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient does not take concomitant medicines.
I had mine 4 years ago, now a very mild case/Suspected vaccination failure; Getting over a very mild case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-May-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media.  The reporter stated that the Shingles Vaccine was must. The patient had shingles vaccine 4 years ago and he/she just getting over a very mild case of shingles. It stayed in 1 area, and did not spread. Additional Supportive Information: The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not reported.
I contracted Covid on 12/09/22 in what has been described to me by the CDC representative as a breakthrough case that needed to be reported. I did not have any adverse reactions to any of the 4 vaccines and boosters.  I had the shot administered by Pharmacy on 12/2/22 (third booster), tested positive for Covid on 12/9/22, and had my doctors appointment and prescribed Paxlovid on 12/11/22 at Urgent Care.
Projectile vomiting; Chills; Dizziness; Nausea; Headache; This is a spontaneous report from a contactable healthcare professional. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 13:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 15Mar2021 at 12:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient previously took codeine (MANUFACTURER UNKNOWN) and vicodin  (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 12Apr2021 at 14:00, one hour after the booster shot the patient experienced nausea and headache. On 12Apr2021 at 17:00, 4 hours after the injection, the patient experienced chills and dizziness, then followed by projectile vomiting for 6 times on 12Apr2021 at 19:00, 5 hours after the injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, headache, chills, dizziness and projectile vomiting was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Mother requested pt. only be given .25ml of a 0.5ml immunization so that is what was given
Approximately 7 days post vax the pt developed skin lesions and malaise. It was generally mild but he felt lousy for about 1-2 days.
Bilateral upper extremity pain progressing over 24 hours. Confusion, lightheadedness, chills, fever, intense pain with motion (R) arm, muscle tenderness whole (R) arm > (L) arm.
My son was a very happy and relaxed baby prior to getting vaccinated. He only cried when he was hungry or gassy and was very social with everyone he came into contact with. My son began having crying fits the morning after he received his vaccinations. The fits lasted day and night for approximately 1 week. When the fits began to subside, I noticed that he would no longer smile, "coo", nor was he able to make eye contact. For lack of a better term, we referred to him as a "baby zombie" that stared off in the distance and would not respond to any stimulation. He continued to remain in this state for approximately 1 month following his vaccinations, at which point he was able to respond to us, and he would occasionally smile. Within 2 weeks of coming out of his "funk" he was back to "normal" again and he has been doing great ever since.
Patient passed out, was completely delerious for over 30 minutes, slurring words, could not see, was dizzy, did not remember anything except getting the injection and wakling up in the hospital.  Pt hit her head when she fainted, no concussion.
pt recv vax 6NOV98 & 21NOV98 exp numbness & tingling of feet, hands, & nose;severe pain of the muscular system by 23NOV98 & dx GBS; Per follow-up dated 10/4/00, the pt continues to experience fatigue, muscle pain particularly in the back, neuropathy of the feet, and insomnia.
Lat atrophy at site of injection into right thigh expanding steadily 2 months post immunization.
No additional adverse events were reported; improperly stored Gardasil 9 and VAQTA administered on 09-SEP-2022; This spontaneous report was received from a Licensed Vocational Nurse (L.V.N.), who was also an office manager/ administrator and refers to a 13-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 09-SEP-2022, the patient was vaccinated with an improperly stored (temperature below 36 Fahrenheit [F] degrees [29.8 F] for 17 hours, 0 minutes and 0 seconds, there were no previous temperature excursions) hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 2nd dose, lot #1780878 was found to be valid, expiration date: 02-DEC-2023, administered in left deltoid for prophylaxis (strength and route of administration were not provided) and influenza vaccine inact sag 3v (FLUCELVAX), lot# 348359, expiration date: 30-JUN-2023, administered in right deltoid (strength, formulation, route of administration and indication were not provided) (product storage error). The patient experienced no adverse event (no adverse event).  This is one of several reports form the same reporter.
Right arm erythema and pruritis. Lasted 15-20 minutes. Resolved with oral Claritin and Famotidine.
Rapids heart beat. Passed out in bathroom hitting head on floor. Out 5-10 minutes
h/a & bad taste in mouth for 3 days p/each shot & stiffness in joints, lt knee, rt pelvis & weakness in lt hand; joint pain;
Break out Covid. confirmed with 2 provided tests.  Also, this was my first time having COVID.  We were on family vacation, eight of us, and we all tested positive for COVID.  2 children and 5 adults were fully vaccinated.  1 adult had only 1 shot and another had 2 shots.  The other 4 adults adults, myself included, had 2 shots of Moderna & had received boosters.  I was prescribed Paxlovid due to asthma and it  rapidly helped to reduce my symptoms.
2min p/vax pt began crying w/a grunt-like loud cry, became cyanotic, cool & clammy;VS BP 90/50, HR 120, breath sounds clear;did not lose consciousness but became obtunded;no med used;
felt sore on the left arm of the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (felt sore on the left arm of the site of the injection) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (felt sore on the left arm of the site of the injection). On 04-Apr-2021, VACCINATION SITE PAIN (felt sore on the left arm of the site of the injection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, SARS-CoV-2 test: positive (Positive) Patient tested Positive 3 days after vaccination took place. On 18-Apr-2021, SARS-CoV-2 test: negative (Negative) Patient tested Negative for COVID virus.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Additional information includes patient second dose is scheduled for 30/APR/2021  Concomitant product use was not provided. Treatment information was not provided.
Patient received a dose of Pfizer vaccine.  It was noted that the vaccine 5 day expiration date/time was 5/12/2021 @ 930 am.  Vaccine was administered to patient at 10:06 am on 5/12/2021.  No adverse reactions noted during observation period.  MD and management team aware.
I have pain in my left arm between my shoulder and elbow tenderness in the front part of my shoulder. I have seen a chiropractor as well as my medical doctor. Soreness still exists.
When she rcvd the vaccine she felt a tingling feeling. Was getting a pain from her fingers to her neck. Went to dr and he was trying to pick up her arm and told her that maybe when she got the shot her nerve  got damage.
Tuesday, 4/13/2021 1:30 PM ? Second shot administered. 4:00 PM ? Pain and heat at injection site. Stiffness through upper arm and extending into shoulder. 5:00 PM ? Extreme feeling of heaviness affects the whole body. Limbs Sitting up or holding a phone/iPad take considerable effort. Had to lay down for the rest of the evening. 7:00-8:00 PM ? Begin to feel feverish and achy. Sensitive skin, muscle pain, sometimes joint pain.  Wednesday, 4/14/2021 The ?heaviness? had abated by Wednesday morning, but the fever and aches continue for a solid 30-32 hours. Fever peaks and stays at 100 degrees Fahrenheit for a considerable time. Normal body temperature is around 97.5.  Thursday, 4/15/2021 2:00-4:00 AM - The fever breaks at some point in the early morning.  Aches begin to subside after the fever breaks. As of 8:00 AM, body temperature is 98.0 degrees. Occasional sweats occurring after fever breaks.  Treatment: Bed rest, drinking fluids (water, Pedialyte, etc.). Did not take Advil or any other pain relievers during this period.