chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness on her arm; there was a raised red lump and a fan shaped red rash; there was a raised red lump and a fan shaped red rash; Initial information was received on 21-Oct-2020 regarding an unsolicited valid non-serious case from a non-healthcare professional.  This case involves a female patient who experienced redness on her arm (erythema), there was a raised red lump (mass) and a fan shaped red rash(rash erythematous), after she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past vaccination(s) included flu shot which the patient received last year and she was tired for four days (Fatigue) and her arm ached (Pain in extremity).  The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via subcutaneous route instead of muscular in an unknown administration site.  On an unknown date, the patient developed a non-serious redness on her arm(erythema), there was a raised red lump (mass) and a fan shaped red rash(rash erythematous) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (latency: unknown).   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for all the events.  There will be no information available on the batch number for this case.
Pt exp 1st dose of Hep B vax in AUG 1991 & w/in 24 hrs following vax pt devel urticaria on face;
Have received an expired dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Have received an expired dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Have received an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Have received an expired dose) outcome was unknown.            No concomitant medications were reported.  Patient received second dose of Moderna vaccine on 29-Nov-2021 with lot number 049E21A and expiry date 11-Oct-2021.  No treatment medications were reported.   This case was linked to MOD-2022-547112 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2022: No new information received.
On January Monday the 24th I woke up with hives all over my body. I noticed that whenever i scratched my body, hives appeared and became itchy. I went to the allergist Thursday the 27th and was diagnosed with dermatographia.
Sore throat, uncomfortable to swallow (reporting because this was not on the listed side effects) Other: fatigue, low grade fever, muscle aches, headache
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/26/21, 2/19/21 and 9/29/2021. Covid + 1/25/22, Presented to ED 1/25/22 after HD c/o SOB and respiratory distress on 4L NC. Pt was previously admitted 12/24/21 to 1/01/22 for bacterial PNA and bacteremia. Discharged on vancomycin and cefepime, and had completed course of flagyl. Also admitted to an outside facility and d/c on 1/21/22 on IV Zosyn. Treated with cefepime and zosyn. Code Blue was called on 1/27/22 and family changed status to DNAR. Expired on 1/27/22.
Fever, chills, fatigue, myalgias, tachycardia, palpitations
Initial report received on 13 November 2009 from a health care professional. A six and a half week old male patient with a history of seborrhea and "not gaining weight" prior to vaccination, the patient weighed 8lbs. 2oz. at the time of vaccination. The patient was treated with Hydrocortisone cream on 02 October 2009 for 5-7 days. The patient's father reported that the patient regressed since receiving a first dose of ACTHIB (lot number UF598AB, SA lot number D0082-1) intramuscularly in the left thigh on 12 October 2009. The patient had rolled over once prior to vaccination and had not rolled over since. The patient's parents initially spoke with physician about an alternative vaccine schedule since their other son has autism, which they believe was a result of vaccination. Therefore, the parents only wanted the patient to receive one vaccine at a time. On 30 October 2009, the patient went to their physician's office asking for the lot number and manufacturer of ACTHIB and stated that the patient was "having some problems". On 13 November 2009 the parents returned to the physician's office and only wanted a "weight check". The patient weighed 8lbs. 14oz. during the visit. They stated that the child had regressed since the vaccine and they were asking questions regarding the contents of the vaccine. However, the parents were adamant that they did not want to see the physician. The nurse suggested they wait to see the physician, but the father refused. The patient was not recovered at the time of the report.
On after all 3 shots, about a day after, I feel the shot affected my mental health. I felt very anxious and had a sever depressive episode. This subsided after about 72 hours after I received the shot. I believe it may have been an interaction with some of the medications I take for my conditions.
ED visit for vaccine side effects, multiple additional ED visits and a hospital admission within 6 weeks of receiving COVID vaccination.
This spontaneous report as received form a nurse refers to a patient of unknown age and gender. On 27-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA: expiration date: 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48 F for 35 minutes, 52F for 95 minutes, 48 F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Client became unconscious, difficult to arouse for 10-15 minutes.  Did respond to voice commands to open eyes.  Pulse weak, thready. diaphoresis
Called 2/8 approximately 1:30 pm asking about sore shoulder that has progressively gotten worse since her Flu shot 12/26. Recommended pt see a physician. Patient contacted pharmacy requesting info regarding her flu-shot received on 12/26. Patient said when she initially received her administration of FLUVIRIN she had mild soreness in her left shoulder. Patient said that the soreness has gotten progressively worse over the course of the last month. Patient states that she has a bump near the administration site. Patient states that it is very difficult to raise her arm.
Hives over body, throat tightened. Was given two Benadryl and observed. Mother picked up.
Muscular pain locally starting 4 d later (x last 3 days). Pt did work out x 3 last week.
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 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Apr2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 17Dec2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 19Jul2022 at 15:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies Penecillin" (unspecified if ongoing), notes: known allergies Penicillin. There were no concomitant medications. Past drug history included: Vicodin, reaction(s): "known allergy: Vicodin"; Vallum, reaction(s): "known allergy: valium". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (19Jul2022) Negative, notes: Paxlovid rebound 3 days after testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Report about covid treatment was Yes. if vaccine received reported as Yes. other medication in 2weeks reported as No. anti viral details was product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 22Jul2022, treatment stop date: 27Jul2022, indication: Treatment of COVID-19. Adverse event reported as Paxlovid rebound 3 days after testing negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
-Gallbladder inflammation I visited my Doctor for, first experience with Gallbladder issues in my life  -Skipped period
Rash and swelling at injection site - started morning after and continues 3 days after Fever, chills, fatigue, body aches - started morning after and lasted for 24 hours
On 2/17/2022 I was administered the second dose of the Pfizer shot  in my right arm. At the time of the shot it was very painful compared to the first shot, and My arm has been in excruciating pain since the day after the injection. I can barely move or rotate my arm, yawning I cannot lift my arm fully at all, lift items, and I?ve been in pain daily. Nothing seems to subside the pain from trying to stretch my arm to taking OTC medication.
Had a pulmonary embolism on 02/16/2022. Two days later released and am now on Eliquis 5mg.
Pt arrived to ER via EMS complaining of SOB after testing positive for COVID on 09/25; O2 levels at 84-85% on room air; pt complained of chills, shortness of breath; hx of htn, diabetes; no tobacco use Treatments: metoprolol 2.5mg q6h, pantoprazole 40mg iv push,
On the second day after receiving the Pfizer vaccine, the mark of the Measles vaccine became red and slightly inflamed. A week later, it is still red and swollen and I feel mild pain in the area.; On the second day after receiving the Pfizer vaccine, the mark of the Measles vaccine became red and slightly inflamed. A week later, it is still red and swollen and I feel mild pain in the area.; On the second day after receiving the Pfizer vaccine, the mark of the Measles vaccine became red and slightly inflamed. A week later, it is still red and swollen and I feel mild pain in the area.; On the second day after receiving the Pfizer vaccine, the mark of the Measles vaccine became red and slightly inflamed. A week later, it is still red and swollen and I feel mild pain in the area.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jul2021 16:45 (Lot number: FA6780) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Measles vaccine (I received the Measles vaccine in the same arm that I received Pfizer vaccine.). The following information was reported: VACCINATION SITE INFLAMMATION (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 11Jul2021, outcome "not recovered" and all described as "On the second day after receiving the Pfizer vaccine, the mark of the Measles vaccine became red and slightly inflamed. A week later, it is still red and swollen and I feel mild pain in the area."; VACCINATION SITE PAIN (non-serious) with onset 11Jul2021, outcome "unknown", described as "On the second day after receiving the Pfizer vaccine, the mark of the Measles vaccine became red and slightly inflamed. A week later, it is still red and swollen and I feel mild pain in the area.".  Additional information: The patient received the Measles vaccine in the same arm that he received Pfizer vaccine. On the second day after receiving the Pfizer vaccine, the mark of the Measles vaccine became red and slightly inflamed. A week later, it was still red and swollen and feel mild pain in the area. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive other medications within 2 weeks of vaccination.    No follow-up attempts are possible. No further information is expected.
Patient with single J+J vaccine who admitted with positive COVID test.  Provider discharge note below:  "This is a 56 YO male with h/o many spine surgeries c/b MRSA chronic infection on doxycycline, acute pancreatitis, chronic pain, HTN, HLD, DM2, OSA, presenting to the ED for evaluation of altered mental status.    History provided largely by wife. Symptoms started 5-6 days ago with decreased PO intake, generalized malaise. 3-4 days ago developed increasing confusion, difficulty  Walking due to instability. Typically uses a cane, but had to start using a walker and holding onto furniture to ambulate. Frequent jerking/twitching that is new. Wife states he is confused, frequently losing track of a conversation and not being able to finish sentences. Fevers 101-102 for the past few days. Notes some increase in his chronic right sided neck pain. No abd pain, no other back pain, headache. Note is also made that he thinks he was recently switched from lasix to torsemide for LEE which is now much better.    In the ER, he is afebrile. Hypoxic on room air, requiring 2L NC. Labs significant for positive COVID, leukopenia, AKI on CKD, lipase 200. MRI spine appears similar to improving from prior. CT abd/pelvis notes peri-pancreatic fluid collection, infiltrates in bilateral lungs c/w COVID. Fluid collection was discussed with IR who did not feel it was amenable to drainage at this time. Admitted for further workup.    Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  Patient was admitted to medicine.  His oxygen requirements initially decreased and then increased.  He was treated with remdesivir and steroids for COVID pneumonia.  Oxygen was weaned slowly.   Due to abdominal pain, he had a CT scan c/w pancreatitis and possible pseudocyst/fluid collection.  He had an IR guided aspiration and drain placement.  He was treated with zosyn x 5 days.  His diet was advanced and he was discharged home.   He had brief episodes of confusion attributed to opioids, which were reduced"
her arm is still red and hurting; her arm is still red and hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 27Aug2021 (Batch/Lot number: unknown) 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: ERYTHEMA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Aug2021, outcome "not recovered" and all described as "her arm is still red and hurting".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bells palsy; This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that a 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 13May2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Reporter states the patient's isn't on any medication so there's no potential interactions. No prior vaccinations (within 4 weeks) within four weeks prior to the first administration date of the suspect vaccine. No additional vaccines administered on same date of the Pfizer suspect. It was reported that the reporter would like to document that one of her patients had an adverse event happen after receiving the Pfizer COVID vaccine. Reporter states because she doesn't feel comfortable reporting all the information, but she would provide the potential side effect from the vaccine. Reporter states the patient had the second Pfizer vaccine on 13May2021 and on 24May2021, this month, she was diagnosed with bell's palsy. Caller states so far, the patient has no improvement, the symptoms are persisting. No investigation assessment. Reporter stated the patient went to urgent care. Patient would be coming to see the reporter, the patient's physician, in a few days. The adverse events require a visit to physician office visit. The adverse events did not require a visit to emergency room. The event was considered as serious (disability) by the physician. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, Bells Palsy cannot be completely ruled out. The impact of this report on 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, Ethic committees, and Investigators, as appropriate.
sore arm after dose one; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received the first dose of BNT162B2 (TRADE NAME UNSPECIFIED; lot number unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced sore arm after dose one on an unspecified date. The clinical outcome of sore arm after dose one was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
I had my vaccination on 10/25/2021. On 10/06/2022 I started not feeling well. I tested COVID-19 Positive on 10/07/2022. I contacted my physician on 10/07/2022 and they prescribed Paxlovid. I am almost better but still residual cough on 10/26/2022.
Started with tiredness, by the next morning, severe chills, very tired, full-body aches, slight headache.  Didn't take temperature when I was feeling so awful but after chills subsided I have a slightly elevated temp of 99.1
Pt received vaccine, several minutes later he became diaphoretic, flushed complained of lightheadedness and some tightness in his chest. BP 128/68, P88.Ten minutes later BP 120/60, P80, flushing and diaphoresis diminished.
Pt went to his PCP, had 105.4 rapid heart rate, diarrhea, elevated b/p 187-85
pt rec'd varicella on 9/5/02, on 9/12 developed fever and pain at injection site L arm; on 9/14 pt Rx Keflex for cellulitis. On 9/15 increased redness and swelling on L deltoid; Keflex dose increased. 9/16 again, worsening redness and swelling, IM Ceftriaxon given today. 9/17 Ceftrixone repeat 1000mg. Decreased swelling/redness. Completed Keflex x 8 days. Twin sib received same imm/same day/same route-no reaction.
Patient received vaccine. Patient fainted into mother's arms about 3-5 minutes later. Patient reported feeling light headed after getting up too fast. EMS responded. Patient vomited 5-10 minutes later while speaking with paramedics.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. While line at the pharmacy to get SHINGRIX dose the reporter stated that the man (patient) in front of her noted he had SHINGRIX shot and had a sore arm. No further detail was available. This case has been linked with case US2018080703, reported by the same reporter.
FELT WORSE; FULL BODY ACHES; FEVER (100.7 F); This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 17:30 for prophylactic vaccination. No concomitant medications were reported. On JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 06-APR-2021, the subject experienced full body aches. On 06-APR-2021, the subject experienced fever (100.7 f). On 07-APR-2021, the subject experienced felt worse. Laboratory data included: Body temperature (NR: not provided) 100.7 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever (100.7 f), full body aches, and felt worse. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Large area of painful redness BELOW injection site (not around it). Maybe 3 by 5 inches. Looks like a large bruise, warm to the touch. Examined at pharmacy 3/14, advised to visit doctor to rule out infection, which he did and doctor determined it was not infected.
Within ten minutes of receiving first dose of pfizer patient reported itchiness of both arms and spread to neck.
Within 48hrs after shot administered pt reports HA, body aches, nausea, chills, pain in arm - unable to lie on arm, then progression to swelling, pain, redness down the arm (still present) 7 days later.
About 10:00 PM Father noticed baby's rt. leg was swollen and red and painful to touch. Mother states upper and lower leg were swollen. Emergency Room report diagnosis was Local Allergic Reaction Right thigh.  Was given Benadryl and Motrin at 10:30 PM and discharged home with instructions to return if symptoms increased and to follow up with Physician.
Change in mood, change in sleep habits, high pitch crying for no apparent reason, and change in appetite.