chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up in severe pain in my left armpit; Swelling and pain in armpit of the arm of injection; I felt a large lump in that armpit; This is a spontaneous report from a contactable consumer or non-health care professional, the patient. A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route and administrated in the left arm on 12Mar2021 at 17:00 hours (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Patient was not allergic to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 14March2021, patient experienced severe pain in her left armpit after woke up, swelling and pain in armpit of the arm of injection, she felt large lump on that armpit it was for 5 days, and then pain was better but the swelling was not gone down. Patient did not receive any treatment for the reported events. On 14March2021, the patient was recovered from the events armpit pain, not recovered from the swelling armpit of the arm of injection, large lump. Information about lot/batch number cannot be obtained. No further information is expected.
My symptoms first manifested the following day, on Friday, October 24th, 2014. I woke up from my sleep around 4 P.M. due to nasal congestion. I noticed small hives and swelling on my face. Throughout that night at work, I went through congestion, sneezing, itching, wheezing, sinus pressure, watery eyes, coughing, vertigo, and nausea. The symptoms on my face (hives & swelling) eventually progressed from the left side of my face to the right side of my face. To help with my symptoms that evening, I took 24hr CLARITIN D, 50mg of BENADRYL and 600mg MOTRIN. When I went to work that evening, my coworkers, who are nurses and physicians, witnessed the severe reaction on my face and prompted me to report it to the Employee Health Department in the morning. After my shift, I went to the Employee Health Department located at my job. The nurse at the Employee Heath Department provided me the link to the web site, so that I could report my vaccine adverse event. The hives, swelling, and itching on my face eventually went away that night. But the rest of the above symptoms lasted for about two months. I also experience soreness in my left shoulder, which was the shoulder where I received the flu shot. The soreness in my left shoulder intensified and worsened into severe pain for several months. The severe pain, which was mainly neuropathic, spread from my left shoulder to my left fingers. The neuropathic pain made it very difficult to sleep, do house chores, and perform work duties. Eventually other pains developed in multiple areas of my body including my knees, hips, and right wrist. Sometimes, the pain would start on my left arm and spread to the rest of my body. I would also have stiffness, numbness, tingling, as well as pain in my joints, neck, face and jaw, all simultaneously. At times, I would feel heaviness, numbness, and tingling in my legs. My calf and various parts of my body ached intermittently, for several months. There was also swelling in my left elbow, left wrist, and left shoulder that lasted for months. I also felt the sensation of something crawling under the skin of my face. I had redness and conjunctivitis in both eyes. The redness and conjunctivitis was worse in the left eye and lasted for several weeks. Overall, there was pain in both of the eyes for months. I felt malaise and general fatigue for several months. For months, I experienced at various times and duration the following: severe headache at the base of my head, vertigo, metallic taste in my mouth, jaw pain, mouth blisters, several skin abscesses, warts, photosensitivity, chest tightness, hypersensitivity in the left arm, memory loss, problems concentrating on daily task, and brain fog.
Upon leaving immunizations clinic pt had labs drawn and had approximately 3 vials of blood drawn. He was waiting in the waiting room to see a provider and fell out of his chair and bumped his head on the floor. Upon approaching pt he was lying on the floor and he appeared to unconscious. Upon speaking to him, he began to foam at the mouth. At that time we turned him to his side and before we could completely get him back on his side, he regained consciousness. Upon obtaining vitals on him, they were all stable and he stated that he felt fine. Dr. examined pt, and diagnosed him as having a vasovagal reaction; however, with the fact that he has to drive to get home, the severity of the impact when he bumped his head, and the fact that he displayed seizure like activity, we asked the pt to go to the hospital to be evaluated.
My right upper arm [felt like the Deltoid muscle] was/is sore and  painful and my range is limited.  I thought it would go away, went for physical therapy but didn't help.  Went back to physical therapy and it's not helping.  I'm scheduled for an MRI on right shoulder/upper arm later this week.
mild cough; little sore throat; feel under the weather; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (mild cough), OROPHARYNGEAL PAIN (little sore throat) and ILLNESS (feel under the weather) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, ATORVASTATIN CALCIUM (LIPITOR), APREMILAST (OTEZLA) and VITAMIN D NOS for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced COUGH (mild cough), OROPHARYNGEAL PAIN (little sore throat) and ILLNESS (feel under the weather). At the time of the report, COUGH (mild cough), OROPHARYNGEAL PAIN (little sore throat) and ILLNESS (feel under the weather) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included acetaminophen, daytime cold and flu medicine.
He had the flu; could not climb up these stairs; Muscle ache; This is a spontaneous report from a Pfizer Covid Vaccine Hesitancy Dialogue Program via a non-contactable other HCP reported. A male patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unknown date at an unknown dose at single dose (dose number unknown, single) for COVID-19 immunization. The patients' medical history and concomitant medications were not reported. It was reported that the patient could not climb up these stairs on unspecified date. The patient who worked there at doctor, could not climb up these stairs. The patient had muscle ache and reported like he had the flu on unspecified date. The outcome of all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
normally, my pulse is in the high 50s or in the 60s.  day after vaccination it was 88.  today it is 3 days later and 81.  very unusual for me.  don't know if related to the vaccine or not and doesn't seem to be doing me any real harm, in any case.  just thought I should let you know.
3cm x 2cm, erythematous, non-vesicular patch at injection site. Fever to 104 as well. Pt also had otitis media on this date.
Hives around neck; feels very bad; Headache; Joint pain; Injection site turned red; injection site started to swell; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives around neck), FEELING ABNORMAL (feels very bad), HEADACHE (Headache), ARTHRALGIA (Joint pain) and VACCINATION SITE ERYTHEMA (Injection site turned red) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives around neck), FEELING ABNORMAL (feels very bad), HEADACHE (Headache), ARTHRALGIA (Joint pain), VACCINATION SITE ERYTHEMA (Injection site turned red) and VACCINATION SITE SWELLING (injection site started to swell). At the time of the report, URTICARIA (Hives around neck), FEELING ABNORMAL (feels very bad), HEADACHE (Headache), ARTHRALGIA (Joint pain), VACCINATION SITE ERYTHEMA (Injection site turned red) and VACCINATION SITE SWELLING (injection site started to swell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Vaccine brand=Pfizer / BioNTech, Vaccine administration date=05Oct2022, Vaccine dose number=5 / Vaccine brand other=Moderna, Vaccine administration date=01Apr2022, Vaccine dose number=4; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 65 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Mar2021 as dose 1, single (Lot number: 003B21A), in left arm, on 30Apr2021 as dose 2, single (Lot number: 041B21A), in left arm, on 02Sep2021 as dose 3 (booster), single (Lot number: 007C21A), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: 084J21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing), notes: Other medical history: HIV; "Duodenal Ulcer" (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 2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Oct2022, outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech, Vaccine administration date=05Oct2022, Vaccine dose number=5 / Vaccine brand other=Moderna, Vaccine administration date=01Apr2022, Vaccine dose number=4". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2023) Negative, notes: After taking Paxlovid, tested negative for 2 days; (04Jan2023) Negative, notes: After taking Paxlovid, tested negative for 2 days; (05Jan2023) Positive, notes: had a rebound with a positive test on the 3rd day. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid.
Severe chills and  . Brain Fog .. Head feel heavy. Blurred vision and shortness of breath at times
pt received a second bivalent pfizer dose. The first on 9/23/22 and the second on 01/30/23.  No side effects reported. Pt just received a second bivalent dose
Narrative: Pharmacy had discovered pt had received expired per beyond use preparation date of covid vaccine booster dose . Pharmacy called patient to provide clinical disclosure that the COVID dose received was expired. Per Moderna, the dose is still effective and does not need to be repeated, but there is higher risk for infection when administering a preservative-free dose after the recommended beyond use date. Patient reports warmth and hardness at the injection site that is improving. Denies redness and fever. Patient has no concerns at this time. Recommended that he seek medical evaluation if symptoms worsen or do not resolve.
This spontaneous report as received from a pharmacist refers to a 14 year old patient. On 17-JUL-2013 the patient received a dose of ZOSTAVAX instead of VARIVAX (Merck). Lot# was not provided. The pharmacist did not have patient or physician details available at the time of the call but she was agreeable to follow up. No adverse effect reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified date, the patients may have received was vaccinated with M-M-R II, subcutaneous (dose and lot number were not reported). The vaccines were improperly exposed to 48.5F for 5 hours 49 minutes (on 01-FEB-2015), and to 48.5F for 9 hours 44 minutes (on 02-FEB-2015), and to room temperatures<77F for 31 minutes (on 24-FEB-2015) for 16 minutes (on 16-FEB-2015) for 15 minutes (on 09-FEB-2015) for 15 minutes (on 06-FEB-2015) for 24 minutes (on 30-JAN-2015) for 31 minutes (on 27-JAN-2015) for 40 minutes (on 15-JAN-2015) for 16 minutes (on 06-JAN-2015) and for 54 minutes (on 30-DEC-2014). There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a other health professional via sales rep and described the occurrence of tingling in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced tingling and numbness of limbs. On an unknown date, the outcome of the tingling and numbness of limbs were recovered/resolved. It was unknown if the reporter considered the tingling and numbness of limbs to be related to SHINGRIX. Additional details were provided as follows: This case was reported by Practice Coordinator. The age at vaccination was not reported. Within few hours after receiving SHINGRIX, the patient experienced tingling and numbness in limbs which lasted only for one day. The reporter agreed to receive follow up from GSK.
Flu vaccine 10/12/15; insomnia; headaches; sore throat; night sweats; rash; low grade fever; L eye twitching; joint pain. Day 16 her only persistence is joint stiffness and L eye twitching.
patient was affected with Covid-19; patient was affected with Covid-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 and dose 2 both via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was an non citizen and living. Patient took Pfizer COVID vaccine (both shots) at Patient traveled in the month of April. Now patient was affected with Covid-19 here and slowing recovering. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
A report has been received from a Health Professional concerning the 100 patients, who had been receiving FLUMIST quadrivalent (intranasal), 0.2mL. On three occasions in FEB2015, their shipment of 100 doses of FLUMIST quadrivalent dropped below 35 degrees in the refrigerator for less than 5 minutes. Specifically, the temperature was 34.9 on 13FEB2015 and 16FEB2015, and 34.7 on 20FEB2015, all for less than 5 minutes. The 100 doses stored outside of temperature parameters were administrated to patients. FLUMIST quadrivalent (intranasal) was continued. The outcome of the event of 100 doses stored outside of temperature parameters were administered to patients was unknown. The report was considered to be non-serious.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (in 1988). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site swelling, injection site itching, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site itching, injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site itching, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: This report was received via healthcare professional (HCP) only email forum. The patient noted that, she was not an HCP but that was the only way to contact GlaxoSmithKline. The age at vaccination was not reported. But, it could be 70 or 71 years old. The patient had local reaction described as unpleasant local swelling, soreness, and severe itchiness. The patient further stated that, the redness and swelling at the site was 2.5 inches in diameter and it was worst. The reaction began to develop in the morning of the day after vaccination and grew for at least 8 days. The patient stated that, the events lasted for 2 weeks and she never had shingles. No further information was provided. For tolerance after the 2nd dose of SHINGRIX for this patient, refer case US2018107167.
Excessively heavy menstrual bleeding which began 3 days after the 2nd dose of the vaccine. Heavy bleeding continued for two days. Two days after heavy bleeding ended, symptoms of fatigue/headache/anxiety  began.
Patient was being seen by PCP.  She suggested that he get a COVID vaccine.  She stated to the nurse that it was ok for him to have the Moderna vaccine as he was "almost" 18.  He received his 1st dose on 7/1/2021.  He was still 17 at the time.  He was monitored for the standard time frame and sent home.  Mother was present at the appointment.  No further orders were given.
NOT REALLY AN ADVERSE EVENT BUT STILL WANTED TO REPORT, PATIENT RECEIVED THE 20 MCG/ML INJECTION ( FOR 20 YEARS AND OLDER) INSTEAD OF THE 10MCG/0.5ML FOR 19 YEARS AND YOUNGER.
Pt presented with parents on 4/30/01 with a 3 day history of fever, left jaw and mouth pain on sour taste (challenge with lemon) and edema and redness and intermittent torticollis on left. MMR given on 4/24/01. At exam, well check, cerumen in ears and allergic rhinitis expected. Development appropriate for age.
NOTIFIED BY A NURSE AT  HOSPITAL. THAT PATIENT WAS TRANSFERRED TO THEM FROM  HOSPITAL WITH CP 5/2/21. STATES PATIENT RECEIVED 2ND PFIZER BY COUNTY HD ON 4/19/21. STATES PATIENT HAD CP AND ELEVATED TROPONINS. ECHO AND HEART CATH NEGATIVE SO MD STATES IT WAS A BAD REACTION TO THE VACCINE.
After receiving vaccine pt sat down in a chair and about 2-3 minutes later pt yelled "I don't feel good." I ran over to pt as she slowly lost consciousness and fell off of chair onto the floor face down. I sat on the floor with pt and monitored her breathing, she never stopped breathing and woke up after about 1 minute. Someone had already called 911 and they were on their way. When she woke up she sat upright on the floor. She was alert and speaking normally, we gave her Gatorade, water, and crackers. She stated she only had eaten a banana all day and she has a history of fainting when donating blood. I asked her if her head hurt because I was not sure how hard she hit her head, she stated it did not hurt. Two police officers arrived and we explained the story, then a medic arrived and we explained the story to him. I told him that she did fall and was face down and hit her head but I wasn't sure how hard she hit her head. He said he would check the pt out, he took vitals and told her that her blood pressure was still a little low and offered to take her to the hospital if she wanted. She stated that she felt ok and declined a trip to the hospital. Her son arrived at the store to drive her home so she wouldn't be driving herself. Her and her son remained in the store for a few more minutes and she said she felt ready to stand up. Her and her son walked out of the store together.
pt recv vax 6JUN96 & 8JUN96 pt exp exacerbation of eczema;No further details were provided;
5 hrs after second dose started feeling extremely tired, took a 2 hr nap, then body aches started then bad chills  set in then 12 hrs after second dose I puked.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Pfizer product on 08/31/2021 and 09/21/2021. The individual had a symptom onset of 12/04/2021 and tested positive for COVID-19 via PCR test on 12/08/2021. The individual was admitted to hospital on 12/08/2021, was transferred to a different hospital on 12/11/2021. They remained hospitalized until their death on 12/16/2021. The individual had complications of a large acute stroke.
As I was injecting the 3rd vaccine ordered for this patient-the patient's mother asked me if we did a pregnancy test on patient. I told her no and asked if a pregnancy test was needed. Mother stated yes. I then asked pt if she was sexually active and she said no. I notified doctor immediately and she ordered a urine pregnancy test. The result of the pregnancy test was positive. I notified doctor immediately. The vaccines that the patient received were Varivax, Gardasil and Menactra. Doctor ordered a referral to OB/GYN. I called doctor's office to get patient an appointment as soon as possible. The receptionist informed the doctor of the situation and he stated patient needed checked in mid-June 08 due to the fact patient states is about 10 days late for menstrual cycle. The receptionist informed med that this patient also had a history of miscarriage in 2007. I informed doctor of this. Patient has an appointment with doctor June 18, 2008. Referral for the appointment was given to Mother and I stressed importance of keeping the appointment as scheduled. Mother verbalized understanding.
p/vax pt exp tremors, stiff neck, back pain & burning feeling in shoulder;pt exp weakness in muscles;pt sought unspecified medical treatment;
Ackey fever 101.5, very tired big red circle around injection site about 3dia.  5 days 6 day still fever but was not to tired I got out of bed. day 7 I was fine but still had the red circle and arm sore.  3 days later the red was gone and the soreness was less and then went away.
Fever, headache, dizziness, rash moving down the arm, tremor. The patient has taken acetaminophen and diphenhydramine.
Drowsy, chills, fever to 104, headache, nausea, heart palpitations.
This spontaneous report was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 08-JUL-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 "10 Single DS 0.5 ml LVls 10SDV", lot # K004148, expiration date 10-MAY-2015 (route was not reported). This vaccine was improperly stored exposed to temperature excursion for a sum of 24 hours at a lowest temperature recorded of 34 degrees F (1.111111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complained involved. This is one of several reports received from the same reporter. Additional information has been requested.