chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old patient who received only HIB portion of PENTACEL.with sterile water, The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. As concomitant medication: patient received PREVNAR, Hepatitis B, PROQUAD on an unknown date. On 12-Sep-2018, the patient received a 0.5 ml single dose of suspect PENTACEL lot C5451AC via intramuscular route in the left thigh. It was a case of actual medication error due to Inappropriate reconstitution technique. It was unknown whether adverse event occurred or not. 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 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.
Pt. experienced fever for 48 hrs beginning 5/14/19 within 8 hrs of immunization.  5/26/19: pt. has red, rash on left lower abdomen.
A report had been received from a Health Professional concerning 11 year old, male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 02-DEC-2014. IT was reported that patient was inadvertently given expired FLUMIST on 02-DEC-2014. The outcome of the event of inadvertently gave expired FLUMIST to three patients was unknown. The report was considered to be non-serious.
Patient was given 2 different manufacturers of Covid vaccine only 12 days apart. Patient was given Moderna Covid vaccine (mRNA-1273) on 1/20/2021. Mistakenly given Pfizer vaccine (mRNA BNT-162b2) on 02/1/2021. No actual adverse effects observed yet
Approximately 10-11 hours after receiving the vaccine, my eyes, lips, throat and tongue began to swell.  I immediately took Bendryl 50 mg.  I had some labored breathing for about 3 hours after taking the Benadryl, and the swelling completely went away about 6 hours later.
RN drew up MMR based on signed informed consent; MMR not on order sheet; MD notified; pt w/o any adverse s/s @ this time;
At 1:30am on 5/16/2021, I began to experience sudden chills and body aches. I drank some water and went to sleep. In the morning, I woke up with more severe body aches, fatigue, and a headache that got worse throughout the day. I ate very little in the morning because smelling food made me feel nauseous. I ate a meal a little after 6:00pm, though I still had a headache, body aches, and chills came back. At around 7:00pm, all of my symptoms began to subside, except fatigue. I went to sleep later in the night and woke up on 5/17/2021 with no symptoms.
Rash on the left side of her neck and jaw; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the left side of her neck and jaw) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced RASH (Rash on the left side of her neck and jaw). At the time of the report, RASH (Rash on the left side of her neck and jaw) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Patient received flu vaccine at 0940 today. Called clinic at 1845 and reported feeling feverish, achy and light headed starting about 1500. No difficulty breathing or swallowing. Denies arm redness or swelling. Is concerned it might be a reaction to the vaccine. Reports he is feeling better.  Wife called clinic back 10 minutes later reporting he husband has a fever of 102 and has a history of pancreatitis and should have never received the high dose flu shot. None of this was reported by patient at time of immunization or when spoke to him 10 minutes earlier. Pt completed vaccine consent form and indicated yes to receiving vaccine in past and no adverse affects to previous vaccines.  Advised patient's wife to take patient to ER for further evaluation
Arthralgia left breast nerve pain Narrative:  12/2020 had an outbreak of shingles on left breast. about 5 days after COVID vaccine left breast nerve tingling started in the same area that shingles had appeared. 7 days later still having nerve tingling and left shoulder pain.  Other Relevant History:
tested  positive for Covid-19 disease before she received her 2nd Pfizer vaccine; tested  positive for Covid-19 disease before she received her 2nd Pfizer vaccine; This is a spontaneous report from a non-contactable consumer (patient) from a program. A female patient of an unspecified age received bnt162b2 (COMIRNATY, solution for injection, Lot number was not reported) via an unspecified route of administration, on an unspecified date, as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive for covid-19 disease before she received her 2nd Pfizer vaccine. The event was assessed by the consumer as non-serious. The patient underwent lab tests and procedures which included sars-cov-2 test positive on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Patient was administered a vaccine outside of expiration date. Product expired 9/30/22 and was administered on 10/7/22.
11 days after booster dose, patient reported to PCP an itchy ash on her face, neck, head, back and axillary. Small red bumps.  No new foods, soaps or bedding.   Provided with hydroxyzine for relief of rash.  Seen in office 3 days later and noted to have had some throat swelling along with the itching.  Received systemic corticosteroids, famotidine and Zyrtec.   referred to allergist.  Rash persisted to dat.   Allergist visit 3/14/22 - idiopathic versus autoimmune uticaria syndrome , possibly related to Moderna booster dose.
Prior to the first dose , I felt completely healthy.  I received the first dose on a Saturday at 9am.  Felt fine most of that day other than my arm being sore, which improved with Ibuprofen.  The following day, I woke up a little achy, but felt better after taking more Ibuprofen.  Around 4-5pm on Sunday afternoon, I started feeling more achy with cold chills (highest temp was 99.5) and congestion.  I would take Ibuprofen and Tylenol, which would help.  On Monday, congestion continued, but the body aches and cold chills went away.   I did feel a little tired, but also did not sleep well due to the congestion.  Did not have any other symptoms other than the congestion and actually felt pretty good.  I worked from home on Monday to be on the safe side.   On Tuesday, I was still having congestion (still no other symptoms) and my work did not want me to return until I got checked by a doctor or get a negative covid test.  Went to an urgent care where I was seen by a doctor and tested for covid (rapid test), which came back positive.  The only other symptom that developed was loss of smell (but not sure if that was just due to the congestion -- it seemed to come and go.  Some things I could smell, some things I couldn't).  I did not lose my sense of test.  The congestion lasted less than a week.  My family quarantined for over 20 days.  We tried our best, but it was hard to isolate myself, especially from my younger kids.  No one else in the household ever developed any symptoms.  Not sure how/where I picked it up at --- We are very careful.  The only other people I saw the 2 weeks prior to testing positive were my parents and in laws at Christmas, all of which have been healthy.
I was given the first shot and sent to an observation room. I felt slightly flushed, it went away. By the evening, I started to feel flushed again. I commented to my wife that I felt like my blood pressure was up. (I don't have high blood pressure). That is the best way I can describe it. I can't recall if the ringing in my ears was noticeable at that time. My the next day I could still feel the flushed feeling and the ringing  was clearly noticeable and increased over time, until it can overcome TV or someone speaking to me. I also had a feeling of persistent light headedness. About Feb 3 I had pain in my ear and went to a clinic. I was diagnosed with a minor ear infection (right). I was given and took a course of anti-biotics. The infection went away but the ringing never did, sometimes it would lessen, but always louder than prior to the shot. I went ahead and took the second shot on Feb 11, thinking my problem was probably and ear infection. I the ringing could get so loud it would wake me up and keep me awake. On Feb20 I woke up to very loud ringing, nausea, and general feeling of unease. I went to a clinic the next day. I was told there was probably some inflammation and was given a steroid shot. After about 4 hrs the ringing lessened and I felt better, the first relief I had from the start. On Feb 23, I saw my ENT Dr. He gave me a course of steroids and ordered a brain MRI. The MRI came back with negative results...no abnormal indications. The ringing is starting to increase again as of the last several days.
Received 4 shots at 4 PM on 9/24. Complained of numbness in left upper arm on 9/25. Saw Dr on 9/25. Treated with Advil. Continued to be difficult to move and sore for several days.
Redness and swelling L leg. Started the day after lZ. Worsened x 24 hours then improved, used ice only.
Pain and soreness in vaccinated arm 6 days after vaccination. Felt tingling in fingers which stopped 3 days after vaccination.
My arm has been painful since the day of the shot. I have a difficult time lifting my left arm without associated pain.
extreme muscle soreness at injection site and along left side of entire body.  Started menstruating 9/18/21; lasted 3 days and is about 1 month before my expected time.  Also cramps were more painful and unlike my normal period. Unable to work that day and had to go home and treat with pain relievers.  Extreme Tiredness- started evening of injection and lasted for 4 days.
Information has been received from a physician concerning a 4-year-patient who on 25-OCT-2002 was vaccinated with a dose of Varivax (Lot # 640153/0823L). On 11-MAY-2006 the patient developed a breakthrough of chickenpox. The patient tested seropositive on 15-MAY-2006. The office scraped some of the patient's lesions and sent them to a lab which confirmed it was a wild-type strain chickenpox and not vaccine-type strain. There was no product quality complaint. Follow up information indicated that the aunt of the patient contracted varicella. No additional information is expected.
Blood in the urine; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Blood in the urine) 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 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 BLOOD URINE PRESENT (Blood in the urine). At the time of the report, BLOOD URINE PRESENT (Blood in the urine) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Additional information received included no new information.
UrticariaPruritus Swelling and hives like for 3 days self treated with Benadryl Narrative:
No additional adverse events; expired doses of PROQUAD were administered to 3 different patients; This spontaneous report was received from a registered nurse and refers to 3 patients of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  It was reported that expired doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) were administered to 3 different patients on 16-APR-2022, 18-APR-2022, and 20-APR-2022, with expiration date of 14-APR-2022 (strength, dose, route of administration, frequency, indication and lot/batch # were not reported).  Product had never experienced temperature excursion and had supported outcome.  No adverse event reported.   Follow-up information has been received from a registered nurse on 02-MAY-2022.  The nurse reported that the patient was a 4 years old female patient.  On 20-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneously on left arm, for prophylaxis (strength, lot number and expiration date were not provided) and with diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX) in the left deltoid, lot number E2L54, expiration date 03-MAR-2023 (strength, route of administration and indication were not provided).; Sender's Comments:  US-009507513-2205USA000842:
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-358717, MOD-2021-358845 (Patient Link).
A report has been received from a health professional concerning a 13 year old male patient. The patient's relevant history, concomitant medications and concurrent diseases were not reported. The patient received nasal FLUMIST QUADRIVALENT on 31-Oct-2014. The medical assistant reported that the patient was dosed with entire 0.2 mL dose of FLUMIST up one nostril. Action taken with FLUMIST was unknown. The outcome of the event of administration of full dose up one nostril was unknown. The report was considered to be non-serious by the reporter.
Suspected vaccination failure; 2 dose shingles vaccine 2 years ago and I broke out in a small area; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient had the 2nd dose Shingles vaccine 2 years ago. However the patient broke out in a small area last fall. This case was considered as suspected vaccination failure since the details regarding lab test confirmation was unknown at the time of reporting.
Site: Pain at Injection Site-Medium, Systemic: tingling hands and fingers,desensation of feet numbness of face-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: pt has raynauds disease
12/11/2011- Recieved the Vaccine; 12/12/2011- lost feeling in face; 12/13/2011- lost feeling in whole body.
Fully vaccinated with Pfizer x2. Tested positive for Covid 01/26/2022.. Expired on 02/15/2022  at Medical Center after being transported to hospital via EMS in Cardiac Arrest.
Information has been received from a registered nurse concerning a 5 year old male who on 27MAY1999 was vaccinated with varicella virus vaccine live. On 23JAN2004 the patient developed 20-100 vesicular lesions. There was no fever. The patient sought medical attention. The pt was prescribed acetaminophen (Tylenol) and diphenhydramine HCl (Benadryl) for treatment. There was no product quality complaint involved Additional information has been requested.
they woke up with chills and body aches; After the second one there is a rash; they woke up with chills and body aches; has a rash on his side that described as hives; This is a spontaneous report received from a contactable consumer (patient's wife).  A male patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as Dose 2, single for COVID-19 immunization. Medical history and family history was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as Dose 1, single for COVID-19 immunization. The patient received Pfizer covid 19 vaccine dose. The patient didn't experience any adverse reaction after first dose. The patient's concomitant medications were not reported. The patient received second vaccine dose around 10 days ago (unspecified date) and had chills and body aches. The patient had rash on his side and was described as hives and it was lingering at the time of reporting. The reporter stated that patient was working as normal. Outcome of events (rash on his side that described as hives) was not recovered and other events (chills and body aches) was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021508896 Same Reporter/drug/AE, diferrent patient
Low oxygen levels; This spontaneous case was reported by a consumer and describes the occurrence of OXYGEN SATURATION DECREASED (Low oxygen levels) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OXYGEN SATURATION DECREASED (Low oxygen levels). At the time of the report, OXYGEN SATURATION DECREASED (Low oxygen levels) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: low (Low) LOW.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Products were reported. No Treatment information was reported.
Patient broke out in a cold sweat, became pale, and unresponsive within 10 minutes of his vaccine 3:20pm.  His breathing rate remained normal so a decision was made to call the patient's wife, who is a nurse, instead of calling EMS.  The patient slowly regained consciousness approximately 10 minutes later.  His color improved somewhat, but he mentioned being tired and cold.  The patient went home under the care of his wife at approximately 3:50pm.
sore arm; This is a spontaneous report received from a contactable consumer. A 64-year-old male patient (husband) received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included non-hodgkins lymphoma. Concomitant medications were not reported. Consumer stated her husband did not have any reactions to the vaccine except a sore arm. Outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Same day of dose 1 after leaving the drive-thru I went to help my friend do her yard work. I was raking and was perspiring a bit and eventually I felt a rash on my neck and thought it was a reaction from the perspiration and heat on my clothing. I went to an urgent care and they couldn't tell me what it was, so I went to dermatology and they looked at it different ways but couldn't determine what it was and I let it go and I don't remember how long it took to go away.
Insidious onset of left axillary pain on post-vaccine day 5, increasing in severity the following day. Worsened by arm movement, limiting function. No LAD. On post-vaccine day 7, a bright streak of erythema and severe overlying warmth developed at injection site. Erythema resolved the following day, warmth is still present. Also, typical injection site pain occurred day of vaccine and resolved over following two days.
Normal pregnancy before vaccination. After first dose I experienced vaginal bleeding and fatigue. After I fatigue, really tired that I never felt before. Felt really tired for two weeks. I miscarried my pregnancy. Baby had no heart beat and not progressing.
arm pain; hypertension; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 17Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Pfizer Covid 19 vaccine, First dose), administration date: 27Jan2021, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; HYPERTENSION (non-serious), outcome "unknown", described as "hypertension". Therapeutic measures were taken as a result of pain in extremity, hypertension.  Additional Information: The patient complained of arm pain for over 10 weeks. Her medical records not with her. She going by what the health officer is asking to relate to Pfizer. She had Arm pain for which treatment taken physical therapy and what medications were involved, she was not sure. She had pain but is unknown if it is the same or worse. prior vaccinations within 4 week was unknown. Unknown if patient is still experiencing this. Patient still has the pain but is unknown if it is the same or worse.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness of the (L) arm started at 10 hrs after vaccination, ass. pain, no swelling. Diameter at 4 inches. Also: fever (T max 38.2 C) x 1 day. Skin lesion resolved after 4 days.