chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Every joint & muscle in body was hurting, bad headache, neck ache, nauseous, heartburn, right arm where Tdap was given red & hard as a rock from the top of my shoulder to just above my elbow. This lasted 5 days. I went to the ER which they wanted to test me for the flu, strep throat & pneumonia. I explained to the doctor what I thought the problem was & he seemed to brush me off. He gave me a prescription for naproxen & nausea. I iced my arm & also took ibuprofen. This last 5 days.
Inappropriate schedule of product administration; This spontaneous case was reported by a consumer and describes the occurrence of INCOMPLETE COURSE OF VACCINATION (Inappropriate schedule of product administration) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Inappropriate schedule of product administration). At the time of the report, INCOMPLETE COURSE OF VACCINATION (Inappropriate schedule of product administration) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
-itching of the face, swelling of lips; then 25mg diphenhydramine IV was administered.  When no relief, and additional itching of throat, famotidine 20mg IV and solumedrol 125mg IV were administered
Patient is a 65-year-old male who presents to the hospital brought in by his family for generalized weakness and decreased appetite for about 2 weeks.  Patient also complains of nausea without any vomiting and shortness of breath.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 91 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Batch/Lot number: unknown) at the age of 91 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "deaf" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose of the vaccine: Given on 16Mar2021; Lot Number: Unknown by caller; Given in patient's left arm), administration date: 16Mar2021, when the patient was 91 years old, for Covid-19 Immunisation, reaction(s): "Pneumonia", "Felt a little off". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Mar2021, outcome "unknown", described as "Patient had first dose of vaccine on 16Mar2021 and the second one on 30Mar2021"; ANXIETY (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Severe Anxiety was worsened/ sense of doom"; PANIC ATTACK (non-serious) with onset 2021, outcome "unknown", described as "panic attacks". The event "severe anxiety was worsened/ sense of doom" was evaluated at the physician office visit and emergency room visit. Additional information: Caller would like to know what can be done at this point regarding the side effects; anxiety and sense of doom, that her father experienced after receiving the Covid-19 vaccine. On 30Mar2021, he received the 2nd shot. Now he had panic attacks. He had anxiety and sense of doom since the vaccine. She said he was being treated already. Caller denied any medications, medical conditions, labs, testing or treatments relevant to report. Caller stated her father is very healthy. Caller stated her father was scared to be alone. Stated that her and her sister had been taking them everywhere with them. Vaccine not administered at "PRIVATE" Facility. No additional vaccines administered on same date of the Pfizer Suspect. Patient did not received other vaccines within 4 weeks prior to the COVID-19 vaccine. No AE(s) following prior vaccinations. No family medical history relevant to AE(s). Relevant tests conducted was reported as none. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
arm was  red and warm; Low grade fever for a few days; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever for a few days), VACCINATION SITE PAIN (arm sore) and VACCINATION SITE ERYTHEMA (arm was  red and warm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced PYREXIA (Low grade fever for a few days) and VACCINATION SITE PAIN (arm sore). On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm was  red and warm). In January 2021, PYREXIA (Low grade fever for a few days) had resolved. At the time of the report, VACCINATION SITE PAIN (arm sore) and VACCINATION SITE ERYTHEMA (arm was  red and warm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-013724 (Patient Link).
My son got it on Monday, so we quarantined him. I woke up Wednesday morning and I cleared my throat and because he had done it like 70 times, I thought oh crap. I tested around 4AM and the test came back positive.  I had fever of 103 degrees, cough, fatigue. I had a lot of right sided sinus pain. I didn't have a sore throat like everybody else had. My doctor prescribed the antiviral because of my autoimmune issues.
Pt reports left-sided tongue tingling and swelling sensation with onset 15 minutes after vaccination. Denies shortness of breath, wheezing, difficulties swallowing. Pt brought to observation area. Symptoms improved and continued to improve throughout visit.
Breakthrough case admission after two vaccines Janssen4/6/21 Lot# 1802068;  Janssen 12/15/21 Lot# 1855191
fainted; heart rate low; vasovagal response; This case was reported by a nurse via sales rep and described the occurrence of fainting in a male patient who received HAV (Havrix 1440 adult) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included oral allergy syndrome. Concurrent medical conditions included allergy to plants.   On an unknown date, the patient received Havrix 1440 adult at an unknown dose and Bexsero at an unknown dose. In May 2019, unknown after receiving Havrix 1440 adult and Bexsero, the patient experienced fainting (serious criteria GSK medically significant), heart rate low and vasovagal reaction. On an unknown date, the outcome of the fainting, heart rate low and vasovagal reaction were unknown.   It was unknown if the reporter considered the fainting, heart rate low and vasovagal reaction to be related to Havrix 1440 adult and Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient had history of oral allergy syndrome and asked if GSK had any additional information reporter could request regarding. The patient who was freshman living in dorm, visited student health services prior to travel. Nurse administered Havrix adult and Bexsero. After vaccinations (approximately 2 weeks ago before from the day of reporting) the patient fainted, heart rate low, ambulance called and stated patient having vasovagal response. The parent of the patient stated she was not sure if related to vaccines as patient had Birch tree allergy and wondered if lot of birch trees on campus. When patient taken to Primary Care Physician, he stated patient was up to date on vaccinations so was not sure why was given Hepatitis A and Meningitidis B. The patient's parent had now reached out to her seeking additional information. Parent requested prescribing information and documentation on why patient given the two vaccines. The reporter consented to follow up.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with ZOSTAVAX for routine adult health maintenance for the prevention of shingles (strength, route, dosage schedule, and lot number were not provided). The vaccine did not prevent shingles as intended (vaccination failure) and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages (injury), and required extensive medical care and treatment. As a further proximate result, the patient suffered and would continue suffering significant medical expenses, pain, suffering (emotional distress) and other damages on unspecified dates. The final outcome of the events was not specified. Vaccination failure, emotional distress, painful injury, damages and herpes zoster were considered to be related to ZOSTAVAX.
I woke up a little after midnight Friday morning with significant arm pain, nausea, diarrhea, fever and intense body aches. The body aches continued for the rest of the night and throughout the next day.   Started to feel better on Saturday, but then developed stiffness on the left side of my neck in the afternoon. Sunday night I woke up in the night with the feeling that the room was spinning, but I had no nausea.  I continue to have fatigue, brain fog and a feeling of vertigo.
This spontaneous report as received from a nurse refers to a 11 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 07-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N019923, expiry date: 28-APR-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: US-009507513-1709USA007012: US-009507513-1709USA007011: US-009507513-1709USA007014.
Loss of consciousness, irregular heart palpitations, nausea. Loss of consciousness lasted less than one minute, recovery took about twenty minutes to become stable to leave the facility; lingering ?wooziness? throughout the day. This reaction was more likely due to vasovagal syncope than the vaccine. Patient has a history of vasovagal syncope.  Arm soreness, fatigue, and headache presented the following day.
had pain and soreness in the arm which has subsided now; There's a bump which is extremely sensitive and is swollen; her hands had gotten puffy; injection site soreness in her left arm; pain in between my knuckles on both hands; This is a spontaneous report from a contactable consumer or other non-HCP. A 52-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ER8729), via intramuscular route of administration, in left arm on 10Apr2021 04:30 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had vaccination on Saturday at 4:30 and probably about 3 hours afterwards, patient noticed her hands had gotten puffy on 10Apr2021. However, patient had pain between the knuckles of both her hands on 10Apr2021. On the left hand, right where the wrist bends, there was kind of like a bump there that is very tender and up to the pointer finger, that knuckle is very tender (of her left hand). There was a bump which is extremely sensitive and is swollen on an unspecified date. On 10Apr2021(maybe 2 hours afterwards), the patient had injection site soreness in her left arm, after four hours her arm became noticeably sore. The patient woke up this morning and had pain and soreness in the arm had subsided greatly on an unspecified date, the soreness is almost gone. The pain with the bending of her wrist and the knuckle joint to her pointer finger on the left hand was staying the same. On 11 Apr 2021(yesterday), this pain came on noticed. She mentions she had not even taken her vitamins that day, she made sure she nothing prior to the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of event pain and soreness in the arm which has subsided now recovered on an unspecified date in 2021, outcome of pain in between my knuckles on both hands and her hands had gotten puffy was not recovered, outcome of there's a bump which is extremely sensitive and is swollen was unknown whereas outcome of site soreness in her left arm was recovering.
On 09/14/2022 I received my Covid-19 vaccine. On 01/08/2023 I started to feel fever, headache, and mild cough.  I tested positive for Covid after reaching out to my doctor. I was prescribed Paxlovid. Symptoms lasted 6 days
tinnitus from old injury doubled in intensity/ tinnitus, it was ringing in the ears; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right arm, administration date 05Feb2021 17:15 (Lot number: EL9261) at the age of 68 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "tinnitus" (unspecified if ongoing), notes: from old injury. Concomitant medication included: OLMESARTAN MEDOXOMIL. Vaccination history included: BNT162B2 (dose 1, administered in the right arm, Batch/Lot number: EL0140), administration date: 15Jan2021 17:30, when the patient was 68 years old, for COVID-19 immunisation. The following information was reported: TINNITUS (non-serious) with onset 05Feb2021 17:15, outcome "not recovered", described as "tinnitus from old injury doubled in intensity/ tinnitus, it was ringing in the ears". Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient reported the Lot number for dose 2 as "EL8261 or that might be EL9261."   No follow-up attempts are possible. No further information is expected.
bruised, hard area size of silver dollar, edema on inj site & under arm, fever @ inj site only;no systemic complaints;ice pack recommended/APAP for discomfort;swelling has gone;small bruises;
Vertigo, lasting roughly 3 minutes.  No other symptoms.  I have had cases of vertigo in the past but have not experienced it in over 2 years, and never longer than 30 seconds-1 minute.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or about 20-JUN-2013, the patient was inoculated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) by a healthcare provider, for the long-term prevention of shingles and/or zoster-related conditions.        Subsequent to zoster vaccine live(ZOSTAVAX) inoculation, patient was treated on an unknown date at the medical office for shingles.  As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The outcome of shingles was unknown.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Error: Wrong Route (SC, IM, etc.).
Breakouts & rash under arms, armpit area. swollen lymphnodes in underarms, breakout starts in center of armpit on affected arm, travels outward in circle around armpit - then travelled a few days later to other armpit
Rash on neck today at school 2 pm, Temp 99 degrees F, advised to see PMD
Tingley feeling in the whole R arm, numbness to the ring and pinky fingers, Lasted for about 4 days
Information has been received from a registered nurse referring to unspecified patients of unknown ages and genders. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, patients were vaccinated with 4 doses of improperly stored RECOMBIVAX HB (dose and frequency unknown, lot # M010671, expiration date: 02-JUN-2018). No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a pharmacist via a company representative refers to a 79 year old female patient with no pertinent medical history. On 03-NOV-2013, the patient was vaccinated with a single standard dose of ZOSTAVAX, subcutaneous (lot # and site of administration not reported). On 06-NOV-2013, 4 days after vaccination the patient experienced increased heartbeat, unspecified changes in her breathing and weakness. The patient went for an office visit with the physician. The outcome of increased heartbeat, unspecified changes in her breathing and weakness was reported as recovering/resolving. The relatedness between ZOSTAVAX and adverse events was not reported. Additional information has been requested.
dizziness, fever 38.8C, lightheaded, h/a, nausea;
second dose was April 2nd and and her one two weeks earlier; second dose was April 2nd and and her one two weeks earlier; she has myocarditis; Sick for several days; This is a spontaneous report from a contactable consumer (patient's mother). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Batch/Lot Number: Unknown), via an unspecified route of administration on 02Apr2021 at age of 50 years old as 2nd dose, single for COVID-19 immunization. Medical history included mast cell disease (mast cell activation syndrome). The patient's concomitant medications included other medication: "She received chemo every 2 weeks for it." The patient experienced myocarditis, sick for several days, both on an unspecified date in Apr2021. The second dose was 02Apr2021 and other one two weeks earlier. Description: Reporter stated, the oldest daughter (patient) had, well all of this happen, little last when they got Pfizer Covid 19 vaccine, she got her last one 02Apr2021 and she was sick for several days and they finally diagnosed her at the reporting date, they taken her to emergency room then finally she was able to see a cardiologist, she said that she had myocarditis and they were just wondering, the reporter realized that it could possibly be from the vaccine because reporter just saw that on news and reporter was calling because some information about. When probed if start experiencing the side effect after the second shot: Reporter stated, "Actually she didn't right way." When confirmed about the patient, reporter stated, "She was the only one their whole family got this. Just her." Treatment: She went to the emergency room 2 times and saw cardiologist. No." The outcome of events was unknown.   Information on the lot/batch number has been requested.
Woke up with decreased appetite and stomach ache, then developed rash on extremities.  By the following morning (9/15) she had rash all over the torso, stomach continued to bother her.  No V/D.
Received Tdap .5 cc IM to RA at 4:40pm - 4:50pm pt c/o chest discomfort, after pt. coughing forcefully. Pt. denied any recent cough/resp. illnesses. 5pm per attending Dr. - admin BENADRYL 50mg. p.o. 5:10pm Albuterol Inhaler. 5:15pm: Pt. states decreased chest discomfort, sl. decrease in HA, c/o still coughing - dry.
Transverse myelitis; This spontaneous case was reported by a consumer and describes the occurrence of MYELITIS TRANSVERSE (Transverse myelitis) 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 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced MYELITIS TRANSVERSE (Transverse myelitis) (seriousness criterion medically significant). At the time of the report, MYELITIS TRANSVERSE (Transverse myelitis) outcome was unknown.            It was reported that some test results for a chronic autoimmune disease are still being awaited but this was some kind of transverse myelitis and an autoimmune reaction as id'd by oligoclonal antibodies.  Concomitant product use was not provided by reporter. Treatment information was not provided.  Company comment: This case concerns a patient of an unknown age and gender with no medical history provided who experienced serious unexpected event of special interest Myelitis transverse. The event occurred seven days after the third dose of mRNA-1273. The rechallenge was not applicable as the event occurred following the third dose of the vaccine. Very limited information regarding clinical course of the event has been provided at this time. It was reported that unspecified test results for chronic autoimmune disease were still being awaited. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-408561 (Patient Link).; Sender's Comments: This case concerns a patient of an unknown age and gender with no medical history provided who experienced serious unexpected event of special interest Myelitis transverse. The event occurred seven days after the third dose of mRNA-1273. The rechallenge was not applicable as the event occurred following the third dose of the vaccine. Very limited information regarding clinical course of the event has been provided at this time. It was reported that unspecified test results for chronic autoimmune disease were still being awaited. The benefit-risk relationship of mRNA-1273 is not affected by this report.