chrisvoncsefalvay/vaers-outcomes huggingface dataset:
With 4 hours of  the vax  my legs began to feel numb and tingly, ,got worse thru the afternoon and night,   headache, Called Drs office  Saturday, still felt like legs were numb,  Sunday same thing, then about 2 pm started to slightly itch all over,. Had a hive beak out on my right cheek, lips are tingling, have a scratchy throat.
No adverse effects; Incorrect product storage; This spontaneous report has been received from a medical assistant and it refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical or concomitant drugs were not reported.  The medical assistant reported that on 10-JUN-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) Injection, lot # S002493, expiration date 23-JUL-2020, for prophylaxis (strength, dose number, dose and route not reported), which was exposed to a temperature range of 15 F to 46 F (36F) for 8 hours. No adverse effects were reported.  This call was made because of a digital data logger.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55 year-old female patient (Weight (kg) 58.97, Height (cm) 168) received BNT162B2, intramuscular, administered in arm left, administration date 11Apr2021 09:10 (Batch/Lot number: unknown, Expiration Date: Unknown) at the age of 54 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 11Apr2021 21:30, outcome "recovered" (12Apr2021), described as "feel pain in my left arm, at site of injection"; HEART RATE INCREASED (non-serious) with onset 11Apr2021 21:30, outcome "recovered" (12Apr2021), described as "my heart began beating very fast"; URETHRAL SYNDROME (non-serious) with onset 11Apr2021 21:30, outcome "recovered" (12Apr2021), described as "I began to urinate, quite forcefully"; TACHYARRHYTHMIA (non-serious) with onset 11Apr2021 21:30, outcome "recovered" (12Apr2021), described as "Tachyarrhythmia lasted roughly 6 hours". Therapeutic measures were not taken as a result of vaccination site pain, heart rate increased, urethral syndrome, tachyarrhythmia. Additional Information: Consumer stated lot number of Covid-19 Vaccine not available as she did not have that with her, she was out walking and she can probably look at up now. she just wanted to confirm to receive vaccine or not. She got the 1st Pfizer vaccination and 12 hours later experienced an adverse co-reaction, her simple question is should she go and get the 2nd vaccine. Consumer was informed about the Pfizer Medical Information and provided with the number. Follow-up (13Sep2021): The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 13Sep2021, this case now contains all required information to be considered valid. Event experienced by patient are added. Follow-up (18Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Patient was feeling shortness of breath and fatigue in January 2022. On May 7, 2022 patient said he had redness, welling of left leg up to the knee.  Since swelling continue so patient went to Hospital which patient was diagnosed with kidney infection and was given an antibiotic.  Swelling in the leg persist so patient was seen at Medical Care. Patient said he had 4-5 blood clot leg.  He said CT scan shows small blood clots in right lung and some blood clot in left lung.  Patient complains of chest pain and discoloration on skin of legs.  Patient was given Eliquis 5mg #70 2 po BID for 7 days then 1 po BID for 21 days.  Patient continues to see primary care Dr..
Child had 10cm x 8 cm inflamed area round right deltoid.  Reported to nurse 6/07/08.
Runny nose; Cough; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported hsitory).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, RHINORRHOEA (Runny nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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. Further information has been requested   Reporter did not allow further contact; 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. Further information has been requested
ITCHING ON PRIVATE PARTS; RASH ON ALL OVER THE PRIVATE PART; ITCHING IN BOTH HANDS, FEET AND INSIDE THIGH AREA/RASH IN BOTH HANDS, FEET AND INSIDE THIGH AREA/RASH IN THIS AREA ARE RED ITCHY; HANDS AND FEET ARE BIT SWOLLEN; This spontaneous report received from a patient concerned a 60 year old male. 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: 206A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced hands and feet are bit swollen. On 19-APR-2021, the subject experienced itching on private part. On 19-APR-2021, the subject experienced rash on all over the private part. On 19-APR-2021, the subject experienced itching in both hands, feet and inside thigh area/rash in both hands, feet and inside thigh area/rash in this area are red itchy. On 20-APR-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on all over the penis, and itching in both hands, feet and inside thigh area/rash in both hands, feet and inside thigh area/rash in this area are red itchy, and the outcome of hands and feet are bit swollen and itching on penis was not reported. This report was non-serious.
Pain in arm. Felt like there was a softball size lump on my arm even though there was no lump. Pain never eased and actually has gotten worse. My left arm is extremely weak now.
Patient was vaccinated with 5-11 pfizer. Patient had turned 12. No adverse reactions.
This is an instance of breakthrough COVID-19 disease after which a death occurred.  The individual was vaccinated with the Pfizer product on 02/10/2021 and 03/03/2021.  The individual became symptomatic with progressively worsening shortness of breath on 04/19/2021 and sought COVID-19 testing on  04/22/2021, which was positive via PCR.  The individual then visited the emergency department on 04/22/2021 and was admitted to hospital same day. They then remained hospitalized until their death on 05/11/2021.   Death Certificate details are as follows:  Part I Cause of Death   A: COVID 19 Part II Other Significant Conditions:    History of Liver Failure
swelling noted of rt deltoid area the day p/inject; sl fever & pain; pt used DPH; adivsed to call MD;
Patient asked for help at 3:20pm. 911 call at 3:27pm. First Epinephrine shot in leg at 3:29. Benadryl   IM in right arm at 3.39. Patient was having difficulty breathing, she has used Epi-pen  before and said it wasn't working. Second Epi-pen  given at 3:41pm. Patient develops nausea, but does not vomit at 3.54pm. EMT arrives at 4.01. EMT leaves with customer to ER at 4.05pm
very bad chills/shaking. Very thirsty. Weakness. Could not lay down flat. Went to  ER, got IV for thirst. Symptoms eased after 2 hours in ER. about 5 hours total.
BODY ACHES; PAIN IN ARM; BLOOD CLOT; This spontaneous report received from a patient who reported on social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) 1 total, dose, start therapy date were not reported 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 21-JUN-2021, the patient had blood clot and reported that arm was killing (pain in arm). On 22-JUN-2021, in the morning, the patient got body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in arm, body aches and blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210651546-covid-19 vaccine ad26.cov2.s-blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sharp/stabbing pain in the right part of the abdomen; Difficulty moving or turning body; Ringing in ear predominantly in right ear; the patient has extensive hearing loss, with hearing loss being worse in the right ear; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS UNILATERAL (Hearing loss worsened a little each day, after a week I could hardly hear(right ear)) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced DEAFNESS UNILATERAL (Hearing loss worsened a little each day, after a week I could hardly hear(right ear)) (seriousness criterion medically significant), ABDOMINAL PAIN (Sharp/stabbing pain in the right part of the abdomen), HYPOKINESIA (Difficulty moving or turning body) and TINNITUS (Ringing in ear predominantly in right ear). On 05-May-2021, ABDOMINAL PAIN (Sharp/stabbing pain in the right part of the abdomen) and HYPOKINESIA (Difficulty moving or turning body) had resolved. At the time of the report, DEAFNESS UNILATERAL (Hearing loss worsened a little each day, after a week I could hardly hear(right ear)) and TINNITUS (Ringing in ear predominantly in right ear) 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.   No concomitant medication was reported. No treatment was reported. Patient reported that a  week after having received the vaccine the patient claims they could barely hear, and were reading lips to communicate. The patient has visited an Ear Nose and Throat specialist physician who has confirmed that the patient has extensive hearing loss. Patient is not planning on receiving the second dose of the Moderna COVID-19 vaccine.; 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. Further information has been requested
Fever, shooting pain, cold-like symptoms, and redness and warmth around injection site starting about 4 hours after injection.
Late afternoon on Wednesday, March 24, I began experiencing stomach pain.  At first I thought it was gas - which would have been rare anyhow.  The pain and tenderness increased a bit through Thursday.  I had no nausea, diarrhea,  or stomach upset - just pain.  On Thursday evening I went to bed thinking that on Friday I would need to call my doctor.   I also thought that I wouldn't be surprised if this could be appendicitis, gall bladder, more.  I awoke Friday with all pain gone, just a little tenderness left.  Everything is well now.  Only later did I think this could be related to my second shot as this was nothing I had experienced before.
Myalgia, Arthralgia, Fever, Diarrhea,  NauseaVomiting, chills Narrative:
Pt had a "severe reaction" following DTP/HIB titer, resulting in hospitalization;
Patient was given an adult dose of Pfizer-BioNtech COVID vaccine on 12/8/21.  See note below: Of note, child dose of the COVID Pfizer vaccine was ordered, but we unfortunately do not have the child dose at our clinic yet, so she was inadvertently given the adult dose of the vaccine (30mcg instead of 10mcg). We explained to the mother what had happened and apologized extensively. We reassured her that this has happened elsewhere before, and no major adverse outcomes have occurred. Discussed that, if anything, she may have a stronger immune response, including increased redness and swelling in the area, as well as systemic symptoms such as fever, chills, fatigue. Counseled mother than she can use tylenol and ibuprofen as needed, and that if she has any further concerns, she should not hesitate to call or bring her back in for evaluation. Also discussed that she will need to get the booster dose at the pediatric clinic, as they currently have the child dose of the vaccine.
-2 days (48 hrs) after injection, had complaints of increased mucus production, intense ache radiating up neck, scapula, shoulder on side of injection. Red erythematous region approx 2 in diameter surrounding injection site, complaint of severe ache on (L) upper body.
Patient called later in the afternoon of her COVID vaccination stating her lips and cheeks were feeling odd, which she described as a tingling feeling. She stated this started about an hour after her vaccine. She had access to benadryl but had not taken any at that point. She was advised to seek immediate medical attention if she started having any trouble breathing or her throat felt like it was closing up. We spoke to the patient a few hours later and she still had some tingling in her upper lip, but was feeling better than earlier. The next day, we followed up again and she had taken a dose of bendaryl the previous evening and she stated that her tongue is now feeling "thick", but her lips and cheeks were no longer tingling.  She also said that she is not having any trouble breathing (and possibly thinking to much about vaccine) - but felt like she could not take as deep a breath as normal.  She said she can perform all daily activities including exercising.
pt recv vax; persistent high pitch cry, inconsolable for approx 2 days; sick child;
sore left arm/hip pain is radiating down to her leg; Knee pain; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), intramuscular in left arm near shoulder on 25Jan2021 10:20 at a single dose for COVID-19 immunization/prevent covid. Medical history included ongoing arthritis diagnosed years ago, ongoing arthralgia, has two titanium knees and she had the hip pain prior to the COVID injection but now her hip pain is radiating down to her leg. Concomitant medications included celecoxib (CELEBREX) from an unknown date and ongoing at 100mg capsule once a day by mouth for arthritis. The patient previously received the first dose of BNT162B2 (Lot: EK9231) administered on 05Jan2021 around 13:00, intramuscular injection in left arm near shoulder for COVID-19 immunization, SHINGRIX two shot dose, she had one in Dec2018 and the second one in Mar2019, stated that it hurt to where she could not even lift the arm. It was reported that on 25Jan2021, patient had the second dose of the vaccine and she had the typical sore arm 6 hours later that lasted 24 hours. She clarifies it recovered completely 48 hours later and she does not have the soreness as of today, states it does not bother her. Reports she also has it to where her knees and hip are hurting her. She has two titanium knees and she had the hip pain prior to the covid injection, but now her hip pain is radiating down to her leg. She has arthritis and with weather changes she experiences the hip pain. Her daughter told her it is a side effect of the shot. She is asking why this hip pain is radiating down. The knee and hip pain started around 9pm on 25Jan2021. Reports it is a tad better but it is painful. She does not have a fever. Treatment for the events knee pain included putting ice and heat on her knee and hip. The outcome of sore left arm/hip pain is radiating down to her leg was recovered on 27Jan2021, knee pain was recovering.
Pt recvd 1st dose of Engerix-B approx 6FEB91 & w/in 48hrs 3FEB91 devel fine rash over trunk, thighs, & arms; Reporter thinks pt, who is an RN; took antihistamine;
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 28-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot# reported as N032958 and expiration date 13-JUL-2020 or lot# N022583 and expiration date 20-JUN-2020 (strength, dose, dose number, site and route of administration were not reported). Administered doses of vaccine were exposed to the temperature excursion below 32 degrees Fahrenheit (29.1 degrees Fahrenheit) for 16 days and the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit (57.9 degrees Fahrenheit) for 15 hours. Data logger was involved. There was no previous temperature excursions. There was no adverse effects reported. This is one of two reports received from the same reporter. Lot number N032958 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).; Sender's Comments:  US-009507513-1809USA000336:
no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    Concomitant medications were not reported.  Total 26 doses from Lot 065K21A Monovalent doses were administered after the BUD to patients. Treatment medications were not reported.   This case was linked (Patient Link).
Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 years old male patient who experienced patient received expired FLUZONE QUADRIVALENT vaccine, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included GARDASIL for Immunisation. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event was occurred or not following the vaccination. 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 Directive 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 the sender: none.
Injection was placed well high of the normal location into the members shoulder joint. Aprox 1.5 hours after vaccination, member developed pain and stiffness in Left shoulder and felt as though he had instability in his shoulder. Upon return to his command, he presented to medical department and had his shoulder evaluated. There was marked decreased Range of motion as well as pain upon movement. Member described it as a dull aching pain. This has continued for 5 days with minimal relief of symptoms.
Patient had seizure (48hrs) within of the 2nd dose of Fluzone PF vial.  Dad stated child did not feel well before shot was checked before shot was given.
We gave Pfizer Covid 19 Bivalent Vaccine twice She had her first one in September and second 2/2023. We were unaware she had the one in September
PATIENT REPORTS INTNESE ITCHING AND HIVE-LIKE WELTS ON AREA SURROUNDING VACCINE SITE. SYMPTOMS STARTED SEVERAL HOURS AFTER RECEIPT OF VACCINE; STATES NO CONCERNS ABOUT PROCESS OF VACCINATION. TOOK BENADRYL AND APPLIED HYDROCORTIZONE CREAM TO AFFECTED AREA. STATES SYMPTOMS RESOLVE BY MORNING AND HAVE NOT RETURNED.
vaccine mixed with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's Comment: The reporter had a few questions regarding the Rotarix vaccine as he/she found that the liquid diluent contains calcium carbonate, sterile water, and xanthan. The reporter just wanted to confirm that there were no actual vaccine components in the diluent. If there were no actual vaccine components in the diluent, would the dose still be valid if the vaccine (powder) was accidentally mixed with sterile water only instead of the liquid diluent that comes in the kit and lastly, did the diluent work as an activator or was it simply used to dilute the vaccine (power). Additional supportive information: The patient received vaccine (powder) which was accidentally mixed with sterile water only instead of the liquid diluent, which led to wrong solution used in drug reconstitution.
more than 24 hours after 2nd injection, I began to feel achy and very cold.  I had a fever of 100.  I took two Tylenol at 8PM and again at 11PM.  Today, I feel hazy and a little achy.