chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shortness of breath; Dizziness; All side effects on safety sheet of moderna vaccine except bad rash; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA AT REST (shortness of breath) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No Medical History).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced DYSPNOEA AT REST (shortness of breath) (seriousness criterion medically significant), DIZZINESS (Dizziness), VACCINATION COMPLICATION (All side effects on safety sheet of moderna vaccine except bad rash) and HEADACHE (Headache). At the time of the report, DYSPNOEA AT REST (shortness of breath) and DIZZINESS (Dizziness) had resolved and VACCINATION COMPLICATION (All side effects on safety sheet of moderna vaccine except bad rash) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs were not reported.  Treatment drug included Tylenol.; Sender'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.
upset stomach; tugging in his throat; does not have taste.; diarrhea; u shaped in the arm of the injection,little rash at the injection site; nausea; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), THROAT TIGHTNESS (tugging in his throat), AGEUSIA (does not have taste.), DIARRHOEA (diarrhea) and INJECTION SITE RASH (u shaped in the arm of the injection,little rash at the injection site) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Stiff person syndrome (an autoimmune disease that is very rare(only 11 people have it and a over 300) and Fibromyalgia. Concomitant products included RITUXIMAB for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), THROAT TIGHTNESS (tugging in his throat), AGEUSIA (does not have taste.), DIARRHOEA (diarrhea), INJECTION SITE RASH (u shaped in the arm of the injection,little rash at the injection site) and NAUSEA (nausea). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), THROAT TIGHTNESS (tugging in his throat), AGEUSIA (does not have taste.), DIARRHOEA (diarrhea), INJECTION SITE RASH (u shaped in the arm of the injection,little rash at the injection site) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: No new information received.
decreased visual acuity starting the day after the vaccine and continuing through reporting day. Patient presented for her second dose and reported the symptoms at this visit.
Developed hives on neck, armpits and wrists but by 12/10/2014 was extensively covered with hives and fussier than usual. Interestingly, although delayed urticaria is known to occur after vaccination with DTaP, it is not common, but I just reported another case to VAERS within the last 2 weeks...same manufacturer but different formulation and lot number (this patient had a DTaP-Hep B-IPV and the other had DTaP).
Patient had a flu shot on 01/05/05. That night patient had a redish, blackish bruise about the size of her palm on her arm where the shot was given. Also had a headache. On 01/12/05, arm was only slightly bruised. Patient did not call her doctor.
Per dad, pt started experiencing symptoms about 2-3 days after receiving flu shot. Symptoms have continued for several weeks to about a month later. Pt reports pain at injection site, which had swelled and formed a large lump. Dad denied hot to the touch.  Dad will follow up with pediatrician.
Itching palms ears head and eyes itching then escalated to itching all over and swelling
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 24-year-old female. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.
This spontaneous report was received from a medical assistant and refers to a 6 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 25-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine needle injected arm, solution leaked out, needle disconnected from syringe, very minimal - none of the solution injected into arm; Dose repeated.
Red itchy bumps started on my stomach on 6 Apr 12 and spread to my legs by 8 Apr 12. Was told to take 1 tablet of BENADRYL 3 times a day for 7 days.
Stuffy nose; left jaw pain; sore arm; lower back pain; bumps in underside tip of tongue; headaches; super tired; earache; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 09Apr2021 at 13:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID), liothyronine sodium (LIOTHYRONINE), citalopram (MANUFACTURER UNKNOWN), cyclobenzaprine hydrochloride (FLEXERIL) and cobamamide (VITAMIN B12); all from unknown start dates and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 19Mar2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021 at 17:00 the patient experienced the events stuffy nose, left jaw pain, sore arm, lower back pain, bumps in underside tip of tongue, headaches, super tired and earache. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcomes of stuffy nose, left jaw pain, sore arm, lower back pain, bumps in underside tip of tongue, headaches, super tired and earache were not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Mother advised on 07 March 2006, age 15 months, child taken to health clinic for Varicella, pneumococcal #4, Hepatitis A #1 and Hib #3 vaccinations. Mom denied any illness or exposure to, stating child was healthy at this time. Approximately 3/8/2006 (day 1 post vaccination) child began vomiting and had copious amounts of malodorous, nonbloody diarrhea without fevers on 3/9/2006 (day 2). On 3/10/2006 (day3) child got up at a normal hour, ate breakfast, played then within a few hours became irritable and fussy (before lunch). Mom was unable to console and thought she might not be feeling well so she gave her some children's TYLENOL (dose per age). Child was reported to be spitting out water and any Pedialyte mom tried to give prior to nap time. Mom advised child was sitting on the floor watching TV whining when she became quiet. Mom saw her stiffen and fall to one side shaking all over with eyes rolled back in head. Child was still in diapers so unknown if incontinent. This lasted for a 1-2 minutes before stopping. Child was lethargic but arousable when ambulance arrived. Child was taken to near-by ER where providers documented onset of 2nd seizure (jerking with total body clonus) and glucose level of 41. She was treated with a D10 bolus and rehydrated with IV normal saline. A head CT showed a non-acute linear scar on the right temporal lobe. They transferred her to a hospital where she was admitted with diagnosis of rotavirus gastroenteritis (stool positive rotavirus but negative for campylobacter, e-coli 0157, salmonella, shigella, yersinia, or WBC) without any further seizure activity or seizure medication being given. Her seizures were "explained by presence of rotavirus". (Records indicate the family dog also had been vomiting during the week prior to child's admission.) Mother advised the child fully recovered and has had no further seizures or seizure medications. Mom advised child has had sequential vaccinations for Hepatitis A and Hib with child complaining of a sore leg x 24 hours otherwise no adverse event 11/3/2006. Child received second MMR and DTaP-IPV booster 8/16/2010 again without any adverse events.
large edematous , erythematous area on entire posterior right upper arm, warm; low grade fever 99.1
This pt expired probably due to SIDS per pt's doctor. No record in pt's chart but pt's doctor said that the death was reported in the newspaper and that the baby was found lying face down in crib. No record at county coroner's office.
Itchy rash, 4 inches by 2 inches started day after receiving flu vaccination.
Booster dose of Moderna given today (0.25ml) given at 2 mos after last dose of primary series.   Patient fine.  no treatment given.  Advised that a repeat dose is not currently recommended.
lt deltoid area 1cm x 1cm of ecchymosis-4x2mm central induration-erythema for ROM of arm-DPH;
Developed rash to body 1 day ago on 6/10/20, started on abdomen and spread to feet. Temp 100.6 today. Rash on bottoms of feet and diaper area.
I received the flu vaccination around 0730 in the ER as I am a board certified EM physician.  Within a few hours the site of injection was aching. A few hours later myalgias set in.  A few hours after that I became chilled and an hour later the rigors started.  I finished my shift and the rigors relented after a hot bath and tea, the myalgias continued, I developed a frontal headache and significant fatigue.  Today on the 15th I still have myalgias, a frontal headache and fatigue.  I have never had a reaction of any kind to the flu vaccine and I typically get the vaccine every year.  I have had a lesser reaction to MMR booster.  It is hard for me to recommend this vaccine this year to the elderly.  I don't think my 86 year old mother could tolerate such a significant reaction as well as I can.  I am pretty sure I will feel better tomorrow.
Uticarial dermatitis on front torso, arms, and upper legs. Slightly red rash with some itchiness/discomfort. Most of rash had faded after six days. No treatment except for aloe vera for comfort.
shoulder muscle pain that has not resolved I did two weeks of tylenol as prescribed by my doctor to no avail It is difficult to lift my arm out from my side which is paunful and makes it difficult to lift items at my work (farming) there is a knot in the shoulder muscle(s)  first dose March 10, 2021 second dose April 8, 2021
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Jul2023 to unknown date in Jul2023. Clinical Course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300257454 same reporter/patent, different dug/AE;
This case was reported by a pharmacist via call center representative and described the occurrence of cold in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced cold. On an unknown date, the outcome of the cold was unknown. It was unknown if the reporter considered the cold to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient getting second dose of SHINGRIX. The reporter asking, if the patient had a cold that was not a hindrance to getting the vaccine. The reported as possible adverse event, due to the patient in question developing a cold after 1st dose of SHINGRIX. No other information was collected. The reporter not gave consent to follow-up.
Information has been received from a physician concerning a female patient who was vaccinated with a 0.65 ml dose of Zostavax. Subsequently the patient developed bells palsy. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a physician concerning a 63 year old female with allergies to ZESTRIL, losartan potassium (MSD) (WAES # 0707USA02778) NORVASC and hydrochlorithiazide (manufacturer unknown) (WAES # 0707USA02779), hypertension and hypothyroidism and a history of Bell's palsy, microscopic haematuria and cardiac murmur who on 23-MAR-2007 was vaccinated in the left deltoid with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot # 656606/0033U). Subsequently the patient developed Bell's palsy. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information from the physician indicated that on 30-MAR-2007 the patient developed Bell's palsy. The patient had left eye droop, left side of mouth droop and tingling left side of face. Unspecified medical attention was sought. At the time of the report the patient still had symptoms. The patient had no adverse events following prior vaccination. Additional information has been requested.
Fever, feverish, body aches, runny nose, sore throat, cough, headache, fatigue, congestion
Itching, began around waist and a couple of spots on top of left foot; spots then spread to both legs; and 8 days out to arms and upper chest area.
Patient had apparent life threatening event the evening of immunization.  Noted to have upper extremity shaking, perioral cyanosis, delayed arousal after episode. The discharge progress note states seizure w/out DGX of epilepsy.
Silver dollar size redness - Site is warm to touch but doesn't bother her. Her PCP rec. ice pack @ site and ZYRTEC for the response, but she used antibiotic.
"the next day (1/8/21) i started with a low grade temp, it never got over 100.2, now i still have extreme fatigue.  My arm was sore for a couple of days only.  The first vaccine was on 12/17/20 and i had 11 days of nausea afterwards"
RASH UP THE RIGHT KNECK TO THE RIGHT SIDE OF FACE AND MOVING TO THE FOREHEAD. BELIEVED TO BE SHINGLE REACTION.
experiening lots of negative reactions that continues to this day; Consumer has decided not to proceed at this time with the second dose to complete the final vaccination process; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of ADVERSE REACTION (experiening lots of negative reactions that continues to this day) and THERAPY CESSATION (Consumer has decided not to proceed at this time with the second dose to complete the final vaccination process) in a female patient of an unknown age 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, the patient experienced ADVERSE REACTION (experiening lots of negative reactions that continues to this day) and THERAPY CESSATION (Consumer has decided not to proceed at this time with the second dose to complete the final vaccination process). At the time of the report, ADVERSE REACTION (experiening lots of negative reactions that continues to this day) and THERAPY CESSATION (Consumer has decided not to proceed at this time with the second dose to complete the final vaccination process) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient evidenced hoarseness and nasal drainage in late morning hours on 10-15-2008.  Hoarseness worsened throughout the day and continued into the next day (the day this report was submitted.)Future prognosis unknown.
soreness on her arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on her arm) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness on her arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (soreness on her arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.  The patient stated she already reported to V-SAFE.
Patient was given 3 vaccines, Tdap, MENACTRA and GARDASIL. After last vaccine (GARDASIL) given patient immediately fainted. She was sitting but slumped over and became very pale. Pt rested in reclining position was monitored and given fluids.
Flinched during the injection and did not get the full injection/no AE; Initial information was received on 09-Nov-2021 regarding an unsolicited valid non-serious case received from a other health professional via (Agency - 00849823).  This case involves a 72 year-old male patient who flinched during the injection and did not get the full injection of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Under dose).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was given.  On 08-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ730AA and 30-Jun-2022) via an intramuscular route at the left arm  for prophylactic vaccination.  It was reported "Pharmacy student is calling to ask if a patient who was getting the FLUZONE HD QUAD, flinched during the injection and she knows he didn't get the full injection, what are the recommendation regarding this".  It was a case of an actual medication error due to vaccine under dose (latency was on same day).   At the time of report, no adverse event reported.   Outcome of event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Information has been received from a nurse and refers to multiple unspecified patients of unknown ages and genders. There was no information about patients' concurrent conditions, medical history or concomitant medications. On multiple unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD lot # N004629 and expiration date of 07-AUG-2018, (route of administration and anatomical location were not reported) for prophylaxis, reconstituted with properly stored sterile diluent (lot # unknown). The vaccine was stored in unspecified temperature range and time frame. Previous temperature excursion was reported as unspecified. No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source. Sender's Comments: US-009507513-1709USA007420.
pt recv vax & p/5 dose was a nonresponder & exp startled awakenings & sleep apnea;dx as having cardiomyopathy w/a cardiac fraction of 30%;
Pt. had all 3 immunizations while seated in a chair. Pt. did not appear anxious. After all shots were given, pt. remained looking at her phone and didn't report feeling any different. After approximately 2 minutes, pt. dropped the phone and began to slump out of the chair. Staff and pt.'s family caught her and lowered her to a seated position on the floor. Her eyes appeared to roll back and she went limp.  After about 10 seconds, she looked up and said, "What happened?" She felt dizzy and nauseous for the next few minutes and felt like she was going to vomit. She was given a cool wash cloth and had a fan on her. She stood up and was encouraged to sit in the chair for a few minutes. Pt. c/o headache. She was encouraged to lie down on the cot with her feet elevated slightly. She remained there for about 10 minutes and then felt well enough to leave with her family. Pt. reports she only had applesauce for breakfast that morning. Mom reported that this is the first time she has reacted to vaccinations like this.