chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an office manager and refers to a 12 months old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 18-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Right deltoid erythematous & edematous.  No Tenderness on palpation
States didn't notice any changes until she was at the gym later. She noticed redness and a small lump.  Later that night she noticed soreness. The next Morning she noticed the redness had spread. I touched the area, it was hard to the touch red and tender when I pressed against it with my finger.
chills, lethargy, joint pain, significant pain in vaccination arm starting 16 hours post vaccine; ending 16 hours later.
white puss spots on upper front gum and upper underside of lip. rinsing with Dexamethazone
chest pain, shortness of breath. normal EKG and cardiac enzymes. Started 12 hours post vaccination, lasted one week.
Just like what she felt during her first dose of moderna covid-19 vaccine, she had a seizure about 10-15 minutes after the vaccine was administered. The pt's episode lasted for about 5 min.  She was sitting on  her  wheelchair and her daughter was speaking to her and holding her hand and head.  Patient was responding to her daughter when daughter ask if pt can hear her.  Patient did say she saw wavy lines while she was having an episode. They left after she felt fine and I spoke to daughter later that evening and daughter said that patient didn't feel tired after they got home  and was eating her dinner. Daughter did speak to her mom's neurologist about the seizure that happened with the first shot and md recommended pt get second dose and not sure why she had a seizure.
pt recv 3 doses of vax 6MAY91, 18JUN91 & 2APR93 & in spite of strong immune status pt devel 2 episodes of HIB rhinitis;sx included irritability, a copious thick green nasal discharge & low grade fever;nasal cult revealed H. influenza vax;
Grandmom got it ,she broke out in shingles/Suspected vaccination failure; She broke out in shingles, suffered the rest of her life with them; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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 not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: The reporter reported this case via interactive digital media. As soon as the patient got Shingles vaccine, she broke out in shingles and suffered the rest of her life with them. The reporter had also seen others done the same. The reporter stated that dont get these vaccines. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact, details were available.
This infant had a macular rash, varible sizes, and fever of 103. To ER vital signs done. Tylenol rectally to continue. The rash subsided 03/01/01.
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 21Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Gastro reflux" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Augmenting, reaction(s): "Known allergies: Augmenting"; Lisinopril, reaction(s): "Known allergies: lisinopril". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medication in 2 weeks. The patient was treated with Paxlovid from 01Mar2023 to 06Mar2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300109702 Same patient, different product, different event;
Two weeks after this shot I woke up with tremors and heart racing. SStarting then, Over a period of the last 7 months I began to have neurological symptoms that have caused me to lose work and my normal life. Tremors, buzz and vibrations in my face,head,chest.Numbness in arms and hands. Insomnia, depression over all the illness, vision disturbance, constipation, urinary hesitancy, sensations of vertigo and all symptoms become worse when I stand or sit.I have to lie down most hours of the day. Exercise intolerance.Cannot  exercise or even walk far.i was a body builder, very fit and healthy and happy before this shot.Have had to take FMLA leave at my work. Cannot  sit up or walk much.Brain fog and lack of concentration and cannot focus my eyes.
Patient developed vesicular rash in dermatomal distribution over thoracic area, c/o pain over this area.
Narrative:  Other Relevant Hx: Symptoms:  Diarrhea & Nausea Vomiting Treatment
The pt developed a rash around the injection site and swollen eyelids, red conjunctivitis, sneezing, hive on body. The pt has autism. Treated with Benadryl.
This 4th dose was actually the only time that I did not get at all sick from the vaccine. However, I contracted COVID (for the 3rd time) at the beginning of June 2022. I was sick for most of June, with it getting worse as time went on. My symptoms for this third case were very different than the first 2. In fact, I was sure it was just allergies for the first week, until it hurt to breathe. At that point, I went to the urgent care near my home and tested positive for COVID. Ten days later, I felt worse than ever. It still hurt when I breathed, I was exhausted with no energy, and I experienced loss of appetite (I pretty much could only eat one small meal a day). I went back to urgent care where they did a chest X-ray and prescribed prednisone and two antibiotics.
Patient fully vaccinated (12/28/21, 1/18/22) with Pfizer  Patient Hospitalized and tested positive for COVID19on 4/7/22
constipation; symptoms of urinary issues; rashes; muscle aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Feb-2021 and was forwarded to Moderna on 09-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (constipation), URINARY TRACT DISORDER (symptoms of urinary issues), RASH (rashes) and MYALGIA (muscle aches) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Diabetes.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced CONSTIPATION (constipation), URINARY TRACT DISORDER (symptoms of urinary issues), RASH (rashes) and MYALGIA (muscle aches). At the time of the report, CONSTIPATION (constipation), URINARY TRACT DISORDER (symptoms of urinary issues), RASH (rashes) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.      The patient's daughter called and wanted to confirm if the symptoms the patient was experiencing were as a result of the vaccine he received or not. Reportedly, the patient was on high blood pressure and diabetes medications (details not provided). The patient developed rashes and muscle aches after his first shot, that eventually went away. He was also experiencing symptoms of urinary issues and constipation. His daughter also reported that the patient did not have HCP (details not provided). Details regarding treatment medications were also not provided.
Patient fainted; This is a spontaneous report from a contactable pharmacist.  A 19-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982), intramuscular in the left arm on 04Feb2021 12:00 at single dose for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient medical history and concomitant medications were not reported. The patient fainted on 04Feb2021 12:00 with outcome of recovered in Feb2021. No treatment was performed due to the event. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.; Sender's Comments: Based on  vaccine-event chronological association, a causal relationship between event syncope and BNT162B2 vaccine 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.
Extreme Muscle Soreness in both thighs, tenderness to the touch, next morning extremely stiff and painful, movement seems to loosen them up a bit, but still painful and sore. Sore all day Sunday so you walk with a limp especially after sitting, up and down stairs hurts the most, still sore on Monday, 3/8/2021
Case number PHEH2011US01585 is an initial spontaneous report received from health care professional on 12 Aug 2011. This report refers to an 11 year old male patient. He was vaccinated with Menveo 0.5 ml intramuscularly on 12 Aug 2011. But, he received Men A Lyophilized powder component which was reconstituted with sterile water instead of Men CWY liquid conjugate. No adverse reaction had occurred following this drug administration error.
No adverse event; patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. as7180b) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date).    It was reported that, the patients involved are all over the age of 65.  No concomitant medications was reported.  Date of administration of vaccine are 22-Apr-2023 (3 patients), 21-Apr-2023 (5 patients), 20-Apr-2023 (2 patients), 16-Apr-2023 (1 patient) and 12-Apr-2023 (1 patient).  No other adverse events have been reported.  No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-721060 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721060:patient 1
Pericarditis and ended up in the Hospital twice. Once to the emergency room on March 8th, 2021 and again onMarch 17th-19th with a diagnosis of Pericarditis. First hospital stay was at hospital and then at Hospital on 3/17.
Hyponatremia with weakness and metabolic encephalopathy and UTI. Treated and discharged. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Patient was given 0.25mcg of Moderna Bivalent Booster, patient was to be given 0.5mcg.  Wrong dose given.
Patient experienced a near-syncope event 20mins post vaccine. Presented to ED. No anaphylactic symptoms expressed. Assessed and released
pediatric patient received an adult dose of Havrix; pediatric patient received an adult dose of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 11-year-old female patient who received HAV (Havrix adult) (batch number 9SDB2, expiry date 13-DEC-2024) for prophylaxis.   On 21-AUG-2023, the patient received the 1st dose of Havrix adult. On 21-AUG-2023, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: pediatric patient received an adult dose of Havrix) and overdose (Verbatim: pediatric patient received an adult dose of Havrix).  The outcome of the adult product administered to child and overdose were unknown.   Additional Information: GSK Receipt Date: 22-AUG-2023 The nurse had a pediatric patient who received an adult dose of Havrix the day before reporting which led to adult product administered to child and overdose. The nurse stated that it was the first dose and what would be the next step. The reporter consented to follow up. This case is linked with US2023114116, same reporter.; Sender's Comments:  US-GSK-US2023114116:2 patient (siblings)
shingles; This is a spontaneous report from a contactable physician. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 22Mar2021, 6 days after the Covid 19 vaccine, the patient developed shingles. Physician doesn't think it was related to the Covid 19 vaccine. Physician prescribed the patient with valaciclovir (VALTREX) and a cream as the shingles were extensive on the patient's abdominal wall. The patient's next dose was on 06Apr2021 and physician was asking if it's ok for the patient to proceed in getting the second Covid 19 vaccine on that day or does the vaccine need to be delayed and if it needs to be delayed how long can it be delayed. Physician doesn't think it's a reaction, she just wants to know how long she can delay the patient getting the second Covid 19 vaccine. The patient developed the shingles on 22Mar2021 but the patient didn't see the doctor until today so he's had the shingles about 10 days. Does the patient go ahead and get the second dose or delay. Physician would like to know how many days you can delay getting the second Covid 19 vaccine. Physician doesn't think the rash is from the Covid 19 vaccine she thinks it's just a coincidence. Patient was in the office exam room. Physician would just like the question answered as the patient in the office. No further information was provided or obtained. Outcome of the event was unknown.   No follow-up attempts are completed; information about lot/batch number cannot be obtained.; Sender's Comments: Event represents an intercurrent medical condition and unrelated to BNT162B2 .
Went to  ER four  times  beginning  on 7/11/2021 was diagnosed with  Parenthesis and Tachycardia  almost hospitalized on 7/15/2021. I am still suffered from  Tachycardia and Parenthesis  and can no longer compete as a swimmer.  This has affected my life
Post left arm injury post Sanofi FLUZONE QUADRIVALENT administration. Staff member reports unable to use left arm from pain in shoulder, numbness in neck and fingers post vaccine.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medications, pertinent medical histories and drug reactions or allergies were not provided. On unknown dates, the patients were administered improperly stored ROTATEQ, lot # M044724 with expiration date on 13-JUN-2018 (doses were not reported). Administered doses of vaccines underwent a temperature excursion from 47 degrees Fahrenheit to 77 degrees Fahrenheit (56.3 degrees Fahrenheit), which lasted for 3 hours and 51 minutes. There was no previous temperature excursion reported. A digital data logger was not involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA005504: US-009507513-1709USA007886:
While patient  remaining in area for 15 minutes after vaccine, she said she started to get light headed.  She ended up on floor, unable to tell us  what happened. Emergency number was called since she was opening and closing her eyes.  While waiting on medical services to arrive, she did state that her arms felt numb/ heavy.  After getting evaluated by medical services, they decided to transport her to hospital for further evaluation.  Patient did have a bump on her forehead.
A report has been received from a Pharmacist concerning a 9 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 05-Oct-2014. The patient inadvertently administered all the FLUMIST QUADRIVALENT dose in one nostril to two patients which started on 05-Oct-2014. The outcome of the event of inadvertently administered all the FLUMIST QUADRIVALENT dose in one nostril to two patients is unknown. The report was considered to be non-serious.
pt mom noticed that pt jaw slightly swollen, this lasted upon waking on 29MAR93 & was gone by next day; pt was not seen by MD nor was any treatment advised;
Allergic reaction on back and around neck, hives, red blotches, itchiness etc. Persistent headaches and difficulty sleeping
40 min seizure 3-15-07. Admitted to medical center-main stayed in hospital one day.  7/17/07 Received hospital medical records which reveal patient experienced convulsive seizure while at daycare lasting 40 min & stopped w/tx at outlying ER. Admitted overnight 3/22-3/23/07.  Had s/s of URI w/low grade fever.  Routinely followed by neuro w/slightly abnormal EEG & unchanged serial head CT scans.   Final DX: Convulsive seizure.
20 cm X 13 cm Erythematous rash over right deltoid, Tx: Lidex cream and Claritin,  48 hours later rash completely gone and patient doing well
No adverse event regarding signs, symptoms. Patient age is not indicated to receive this dosage of Pfizer-Bivalent since she falls into the pediatric category.
Approximately 3 hrs after shots, started crying and squirming, turned into high-shrill shrieking non-stop for five hours until we got him back to doctor's office and they sedated him with Benadryl. Was very cranky and sleepy for two days. Seems to have recovered.
Pt given MMR SQ in R thigh 5/31/06. Guardian noticed redness on 6/1/06. Pt brought in to see DR on 6/2/06 at 10:00am with SX of right leg swelling, redness and quarter sized blister at injection site of MMR. DR diagnosis with local hypersensitivity to MMR and treated with Benadryl, Prednisone and Augmentin, and F/U if SX persist.
Shots given 7/14/14 at 10:30 AM, that afternoon developed fever (felt hot) rash at site of MMRV noted about 24 hours after shot given - (L) thigh - red, sl. raised irregularly shaped wheal 4 x 3 cm, itches, not getting bigger, did have sore throat AM 7/16/16. Otherwise feels well.
Woke up at 2:30am with headache, fever of 101, chills, and body aches. Took Tylenol extra strength and advil. Continued to take Tylenol throughout the day 2/3/2021. Pain and swelling at injection site as well. Symptoms of fever/body aches resolving by the end of the day 2/3
4:30 P pt's mom called clinic stating patient had wok up consonsolable, increased crying, redness and swelling at injection site, left leg.
Fainted, BP 89/59, O2 sat 99%. Patient fell and hit her head under the chin. Patient has a history of low BP with shots. Sent to ED.
Patient received vaccine on 4/4/19, the next felt chills, body aches. At dinner time patient felt face swelling, throat, swelling and had a hard time swallowing. Patient went to urgent care, was told to go home and take BENADRYL, SYRTEC, and PEPCID for 3 days. Patient has no after affects.
Patient received 1st Moderna Booster on 12/29/2021. Patient received 2nd Moderna Booster on 4/6/2022, but was not eligible for 2nd Moderna booster until 04/29/2022. Patient had no immediate adverse reaction after administration of 2nd Moderna Booster. Patient was contacted on 4/7/2022 and denied any adverse reactions.  Patient reported that he had a "little less achiness than previous doses".
Strong chest pain that lasted several days.  One day was so intense I had to sleep upright.  I would get winded walking up a flight of stairs.  Normally I run 3-4 miles for workouts.  I had pericarditis in my 30s and it felt very similar.
Received Hepatitis A inoculation on 2/10/09 at approximately 11 am. At 10:30 pm experienced symptoms similar to attack of food poisoning. Vomited and diarrhea for 2-3 hours. Severe stomach pains. Subsided at 1:30am.