chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/22 Vaccination Unknown dates; around the holidays 1.5.2021 - missed 2 weeks of work.  I started the propranolol.  I ended up with extreme HA, vomiting, syncope, Stomach pain, couldn't keep anything down. Lasted for 2 weeks.  *2nd shot - same symptoms
upper back, through shoulder blades pain/lower back pain; upper back, through shoulder blades pain; This is a spontaneous report from a contactable 56-year-old female nurse (patient, self-reported). A 56-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE (age at the time of vaccination was 56 years), Formulation: Solution for injection, Lot number and Expiry date: unknown), dose 2 via an intramuscular route of administration, in the right arm, on 21Jan2021 at 09:15, as single for COVID-19 immunization. The patient's medical history included hypothyroidism, and patient historical vaccine includes, received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: unknown), dose 1 via an intramuscular route of administration, in the right arm, on 31Dec2021 at 02:00 PM, as single for COVID-19 immunisation and had reaction right groin pain and right hip pain. The patient's concomitant medications included levothyroxine sodium (SYNTHROID), clonazepam, vortioxetine hydrobromide (TRINTELLIX), colecalciferol (vitamin d), amitriptyline. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received second COVID-19 vaccine on 21Jan2021 and noted upper back, through shoulder blades pain on 22Jan2021, resolved after 24hours. The patient was not tested for COVID-19 since the vaccination. The patient did not receive treatment medications. Outcome of the events back pain, arthralgia was recovered on Jan2021.  Information on the lot/batch number has been requested.  Follow-up (15-Apr-2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
1 of 2 pts who devel a rash near site of Tetramune vax;also recvd MMR @ same visit;reporter could not recall pt's name;this pt devel a large 9size of baseball round rash, sl erythematous approx 1-2 inches below tetramune site
Post vaccine pt became dizzy, felt lightheaded, and anxious. Pt transferred to med obs via wc. Pt reported feeling better after laying on stretcher. Vitals obtained and monitored. Pt had no complaints of chest pain. Pt had no complaints of SOB. Pt released at 15:27. Vitals as follows: 1514 LYING BP 119/68 HR 60 RR 18 SpO2 97% 1520 SITTING BP 120/55 HR 60 RR 18 SpO2 97% 1524 STANDING BP 99/62 HR 68 RR 18 SpO2 97% (PT BASELINE)
Subconjunctival haemorrhage in right eye, itchiness in the eye. Ongoing on date of report. No treatment required.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with PEDVAXHIB (route, dose and lot # were not reported) that was improperly stored. No adverse symptoms reported. The outcome of patients received improperly stored PEDVAXHIB was unknown. This is one of several reports from the same source. Additional information has been requested.
Patient, fainted, flushed paramedics came low blood pressure pulse, sweating gave water revived.
Within a few hours of my second shot, I had flu-like symptoms, intense pain in my left arm, high fever, severe nausea and fatigue.  Within 4-5 days the flu-like symptoms had went away.  A few days after my flu-like symptoms went away, my "restless leg syndrome" sensation came back strong.  It kept me up for two nights, causing my body to move involuntarily, no possibility to sleep a wink.  Upon nearly completing my 2-week post 2nd vaccination, I started experiencing a burning sensation on my head, which at the time I mistook for sunburn.  Quickly, this sensation clued me into the realization I actually had shingles.  Symptoms of this started strongly on June 28, 2021; I'm unsure of when this started exactly.  I went to an ER as well as urgent care, for my diagnosis.  My doctor told me I was the youngest patient she's ever heard of having shingles, but since some of my other symptoms dealt with nerve issues - this could be where it stemmed from as well; I did have chicken pox as a child, so it was shocking I had it this badly.  My shingles has been isolated to the left side of my face thus far, in my eyebrow, left side of my entire hairline, inside my left ear, down my jaw and forehead.  I have a lymph node behind my left ear swollen to the size of a marble; all areas very sensitive to the touch.  Extremely painful!!
Shingles rash 5 days after 2nd shot. First two days after the shot I felt ill with general unwell, lymph nodes hurt, headache, tired. Day 4 noticed pain on stomach and back area and day 5 noticed rash. Day 6 rash was significantly worse and painful. Confirmed shingles on day 6 from doctor.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 13-OCT-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Severe ataxia to the extent patient was unable to walk or stand up without assistance.  Evaluated at a local Medical Center where code stroke was called, cardiac and infectious evaluation were done.  No cause of his ataxia was found.  Patient returned to baseline function after another 24 hours.
PAIN IN JOINTS STARTED 21 HRS AFTER 2ND VACCINE SHOT TOOK ADVIL; SHORTNESS OF BREATH/DIFFICULTY BREATHING.  48 HRS LATER HAD ANOTHER SLIGHT EPIDODE OF SHORTNESS OF BREATH
This case was reported by a consumer via call center representative and described the occurrence of myalgia of lower extremities in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis. On 10th December 2021, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2021-2022 season. On 11th December 2021, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced myalgia of lower extremities and tiredness. On an unknown date, the outcome of the myalgia of lower extremities and tiredness were not recovered/not resolved. It was unknown if the reporter considered the myalgia of lower extremities and tiredness to be related to Shingrix and Influenza vaccine Quadrivalent 2021-2022 season. Additional details were provided as follows. The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine into left arm and flu vaccination on the same day in his opposite arm and next day he felt very tired and that his leg muscles were sore. The reporter called today (day of reporting) to requested a copy of the product insert for Shingrix. The reporter was given medical disclaimer. The reporter was referred to health care professional. The reporter was offered medical information phone number for HCP reference. No further information reported. The reporter consented to follow-up.
During post vaccination observation period c/o dizziness,, feeling weak, requesting to lay down.  C/o mild acute headache.  History of chronic Atrial fibrillation on Coumadin, allergic to IV dye. Transported to ED, EKG in atrial fibrillation, lab work within normal limits, Given Benadryl and Pepcid, symptoms resolved and discharged to home.
Patient developed large rash that she described as hard, warm, slight itch and somewhat painful. Reported to us on 8/31. Patient was instructed to take ADVIL, BENADRYL and watch closely. Patient was contacted on 9/2 for follow up, rash was getting better, no longer bothersome but still there. Rash getting smaller.
back was aching/back hurt; felt their muscles like tired/exhausted; muscle aches/body hurt so much; felt very tired; arm hurt so much; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt so much), BACK PAIN (back was aching/back hurt), MUSCLE FATIGUE (felt their muscles like tired/exhausted), MYALGIA (muscle aches/body hurt so much) and FATIGUE (felt very tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included VITAMIN D [VITAMIN D NOS] and VITAMINS NOS for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt so much). On 15-Mar-2021, the patient experienced BACK PAIN (back was aching/back hurt), MUSCLE FATIGUE (felt their muscles like tired/exhausted), MYALGIA (muscle aches/body hurt so much) and FATIGUE (felt very tired). The patient was treated with PARACETAMOL (TYLENOL) for Pain and Pain in arm, at an unspecified dose and frequency. On 16-Mar-2021, PAIN IN EXTREMITY (arm hurt so much), BACK PAIN (back was aching/back hurt), MUSCLE FATIGUE (felt their muscles like tired/exhausted), MYALGIA (muscle aches/body hurt so much) and FATIGUE (felt very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Additional concomitant medications included unspecified thyroid medication.
Mother brought child to ER on 2/16/03 with a complaint of a knot on the pt's right anterior thigh. Symptoms started on 2/12/03. She was no better on 2/16/03. Mother states knot is still the same size (size of a quarter). The mother was advised to use ice pack alternating with warm cloth, Benadryl every 6 hours and Tylenol or Motrin every 4 hours.
Individual had sick visitors at her home recently then became symptomatic on 12/10/21. Positive Covid test on 12/11/21. Notified about positive result. Currently in isolation for 10 days.
Rapid descent into waves of nausea and vomiting for 4 hours. Fine after and before.
dizziness; tired; soreness chest; breathing problems; headache; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced tiredness, chest pain, difficulty breathing and headache. On 24th April 2019, the patient experienced dizziness. On an unknown date, the outcome of the dizziness, tiredness, chest pain, difficulty breathing and headache were not recovered/not resolved.   It was unknown if the reporter considered the dizziness, tiredness, chest pain, difficulty breathing and headache to be related to Shingrix.  Additional details were provided as follows: About six hours later, the patient started having dizziness.  He also felt more tired, his chest was sore, problems breathing and headache. The patient consented to follow up.
6-26-06 Pt states "I had fever, body aches, rash all over body, swollen lymph nodes in neck"
Injection time 1302. Symptoms: Lightheaded and flushed. Per pt's daughter, felt symptoms around 1325. Pt. has history of diabetes and also currently taking antibiotics for UTI. BP 110/78. Symptoms improved 1335. Observed pt. until 1355. Pt. is feeling better and in stable condition at the time she left.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "mild asthma" (unspecified if ongoing); "known allergies: Aspirin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid from 25Feb2023 to 01Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300107549 same patient, different drug and event.;
A serious report of anosmia has been received from a physician concerning a nine-year-old female. No relevant medical or drug history information has been reported for this patient. The patient received the initial dose of FluMist on an unknown date in 2005 and continued to receive FluMist on unknown dates in 2006 and 2007. On an unknown date in the summer of 2005, the patient began complaining of not being able to smell anything. Reporter was not sure whether this occurred before or after receiving the initial dose of FluMist. The patient continued to complain of not being able to smell, but continued to receive FluMist in 2006 and 2007. A neurologist was consulted and a MRI was performed in Sep 2007 with normal results. A smell test was also performed in Sep 2007 and the results were abnormal. In Oct 2007, the patient's primary care provider called the sponsor's medical information department to ask if anyone had lost the ability to smell after receiving FluMist. While obtaining follow up information, the primary care physician stated "the smell test indicated that the child could not smell anything" and that she "was not sure when a child recognizes the sense of smell or the absence of the sense and was not sure whether the loss of smell could be a result of a virus or was present at birth". The primary care physician would not release the contact information for the neurologist. The event has not resolved and is considered to be a permanent disability by the primary care provider. No additional information information is available. The primary care physician was unsure whether the patient would continue to receive FluMist. The patient did not experience a rechallenge while receiving the suspect product. The reporter did not provide a causality assessment for the adverse events reported.
Information has been received from a nurse concerning a 17 year old female with acne with a history of 0 pregnancies and 0 live births who on 31-JUL-2007 was vaccinated IM with the first dose of with Gardasil included benzoyl peroxide (+) clindamycin phosphate (BENZACLIN), gel BID for the treatment of acne. On 15-AUG-2007 the patient experienced abdominal pain and an ultrasound was performed which confirmed a pregnancy. it was believed that the patient was 7 weeks pregnant and that her due date was 01-APR-2008. At the time of this report it was unknown if the patient had recovered from the abdominal pain. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007.  Follow up information was received from the nurse which stated that on 24-AUG-2007 the patient had an elective abortion.  Additional information was not provided.  At the time of the report the patient had recovered from the event.  Upon internal medical review the elective abortion was considered to be an other medical event.  Additional information has been requested.
SHARP, THROBBING PAIN FROM MIDDLE OF NECK DOWN TO LEFT SHOULDER. STILL UNABLE TO USE LEFT ARM 3 DAYS LATER. HAS DR APPOINTMENT SCHEDULED FOR 5/8/2018.
Patient came to several clinics for Pfizer Bivalent boosters even though the patient did not require or meet the criteria for any more COVID vaccinations. It is assumed that the patient took advantage of County's $25 gift card incentive program for patients that receive COVID vaccines. Pt was given unnecessary Pfizer Bivalent booster and asked to wait the required 15 minute wait period and did not complain of any effects from vaccine prior to leaving clinic.
p/vax pt devel severe break-out w/red blisters all over body; (massive anaphylactic rxn); Steven Johnson syndrome
On the evening of April 11th after receiving the J&J COVID shot, my entire left arm was very sore and hurt to move. I knew to expect this because it was listed as a side effect. It was very painful to the point I could not sleep on my left side. If I did, it would hurt really bad. The extreme pain persisted for two weeks. As time went on, I noticed my left arm would be sore occasionally. During the summer of 2021 and onward, I noticed a pattern that when I would have a runny nose or cold-like symptoms, I could feel the soreness from the injection site through my arm. I thought the vaccine was possibly "working" and that's why my arm would be sore. I have grown very concerned about this because it is starting to feel like a disability with chronic pain that began the day I was injected with the J&J vaccine. The pain comes and goes but this was not my normal prior to the vaccine. I avoid sleeping on my left side because it hurts if I do. I feel a buzzing feeling sometimes in my left hand. I'm reporting this today because I am experiencing the pain again and I undoubtedly believe it is related to the vaccine.
Patient experienced vasovagal event after receiving dose of Janssen Vaccine. Spontaneous resolution after being put in supine position. Patient observed for additional 30 minutes at which point he left for home.  Patient was called an hour later to see how he was feeling. He reported he was feeling fine.
12Oct90 pt vax 2nd dose; exp tiredness.  Pt undergoing testing for Epstein-Barr.  Results positive.
After the injection, local soreness but not noticeable unless moving my arm.  Day 1 after the shot had no symptoms. Woke on Day 2 around 5am, with chills, nausea, dizziness, vomiting, shortness of breath, severe headache.  Symptoms persisted until approximately 2pm the same day. Headache was persistent, as was dizziness, but nausea and chills were intermittent.  4 incidents of dry heave vomiting.
redness at the injection site; Injection site a little hard; Injection site a little puffy; Injection site a little itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE INDURATION (Injection site a little hard), VACCINATION SITE INFLAMMATION (Injection site a little puffy) and VACCINATION SITE PRURITUS (Injection site a little itchy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE INDURATION (Injection site a little hard), VACCINATION SITE INFLAMMATION (Injection site a little puffy) and VACCINATION SITE PRURITUS (Injection site a little itchy). At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE INDURATION (Injection site a little hard), VACCINATION SITE INFLAMMATION (Injection site a little puffy) and VACCINATION SITE PRURITUS (Injection site a little itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.