chrisvoncsefalvay/vaers-outcomes huggingface dataset:
small redness at the site injection; localized redness about the size of a baseball; localized redness which is is sore when I press on the site; localized reaction today with  redness and tenderness; chills / shivering; mild myalgia; injection was very painful in her shoulder joint and was sore; This case was reported by a nurse and described the occurrence of injection site erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site erythema, localized erythema, pain localized, tenderness, chills, myalgia and pain in joint involving shoulder region. On an unknown date, the outcome of the injection site erythema, localized erythema, pain localized and tenderness were not recovered/not resolved and the outcome of the chills, myalgia and pain in joint involving shoulder region were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, localized erythema, pain localized, tenderness, chills, myalgia and pain in joint involving shoulder region to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on her left arm. The patient experienced localized redness about the size of a baseball, which was sore when pressed on the site and also had a small redness at the site injection. The patient had localized redness and tenderness until the day of reporting. The injection was very painful in her shoulder joint and was sore for a couple of days and then resolved. The patient also had chills and shivering with mild myalgia which resolved in a day or so. The reporter consented to follow up.
Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN and CELECOXIB (CELEBREX) for an unknown indication.    On 26-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 VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
Day of vaccine had lightheadedness, stiffness and pain in both ankles, fatigue. Puffiness in face and eyes. Fatigue has increased, experiencing shortness of breath while walking, walking up stairs, trying to exercise. Occasional chest pain, Having to take 2-3 hour naps everyday. Headaches every day all day. Tinnitus in both ears, tingling and burning on brain. Weakness throughout body. Intense nausea daily and stomach cramps/abdominal migraines. Indigestion started 20 minutes after the vaccine. Gait issues and unsteadiness. Stiffness in neck and shoulders. Sore throat, congestion, and mild cough. Flushing of face and burning of skin both in face and legs. Many of these symptoms also happened with the first dose.
His first Pfizer covid vaccine was administered 5 months later on July 8, 2021.   Twelve days later on July 20, 2021 he reported to medical with fever, chills, headache, loss taste/smell, myalgia, arthralgia, and chest pain 4 to 48 hours after receipt of his vaccine with resolution of symptoms another 48 hours later.   His chest pain was described as deep achy pressure to sub-xyphoid area, non-positional, had no radiation or triggers.  He has a history of GERD.  Follow up echo in November 2021 was normal with "no findings of covid sequalae".     Disease: 1. He developed covid disease Aug 31, 2020 with c/o cough, body aches, fiver, sinus pain, loss taste/smell, xyphoid-chest pain, and left flank pain.    2. Over next 2-3 weeks he recovered with records showing evaluations by cardiology occurring October 19, 2020 thru November 25, 2020 for continued DOE and xyphoid pain. Records note normal EKG and echocardiogram. No troponin or cardiac labs drawn.  All s/s had resolved as of December 2020 except for DOE and HA's. In January 2021 pulmonology evaluation for continued DOE had normal PFT.    Vaccines: 3. His first Pfizer covid vaccine was administered 5 months later on July 8, 2021.   Twelve days later on July 20, 2021 he reported to medical with fever, chills, headache, loss taste/smell, myalgia, arthralgia, and chest pain 4 to 48 hours after receipt of his vaccine with resolution of symptoms another 48 hours later.   His chest pain was described as deep achy pressure to sub-xyphoid area, non-positional, had no radiation or triggers.  He has a history of GERD.  Follow up echo in November 2021 was normal with "no findings of covid sequalae".    Disease 4. As of October 2022, he still c/o of URI like symptoms of HA, PND, congestion, cough, sore throat on and off; and did experience covid disease again in January 2022.  No report of chest pain was documented with this event or since.   Assigned case 10597  = No diagnosis of myopericarditis identified despite given medical exemption for it to further covid vaccines.
Patient fainted and fell to the floor shortly after receiving flu shot. Patient had regained consciousness by the time I arrived. Patient was alert and responding to questions at that time. EMS arrived within about 5 to 10 minutes and transported her to the hospital.
16:45 reports (L) arm numbness starting @ (L) shoulder extending to (L) hand. EMS notified for evaluation. B/P 190/102. P73, Glucose 109 (2° post prandial) O2 sat 100% Pt. refused transport to local hospital.
Patient requested MMR, dose#2 and ZOSTAVAX. Vaccine orders were proposed by MA. ZOSTAVAX signed by MD and MMR given verbal approval. Patient received vaccines. After patient left clinic, it was noted in chart that she had reported receiving immunosuppressant drug RITUXAN (contraindication for live vaccine administration while receiving this medication). After further investigation, it was determined that patient had not received this medication for the pat 12 months. However, she is currently on oral immunosuppressive therapy, taking 20mg of methotrexate weekly. PCP (office where vaccine was administered) consulted with rheumatologist. Decided to recommend patient hold methotrexate x4 weeks. At this time, no adverse reaction has been reported.
Major pain in arm and restriction in range of motion. 14+ days major diarrhea and flu like symptoms, tired, body ache, major headache. Has shortness of breath after second dose and went to hospital for such.
Severe myalgias starting 3/27/07 to the point of being unable to sit up or walk. Fever stated 4/4/07 PM. With in 1 hr of onset of fever, pt became hypotensive and had a flushing rash. She was admitted to the PICU and supported with pressors. As of 4/6/07, she is improving. No source had been identified. CK <7, BCXs neg. 04/19/07-records received from facility-DOS 4/4-4/10/07-DC DX: Hypotension. Rash. Presented with 2 week history not feeling well with significant myalgias. C/O sore throat, throat culture negative. Nausea, diarrhea. Developed progressive muscle pain. RX with dopamine. Source of infection may have been area of inflammation on back of earlobe at earring hole site.
Sharp shoulder pain when lifting objects & discomfort while sleeping (to the level that she sleeps only on one side).
slight numbness in my left cheek-same side as injection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (slight numbness in my left cheek-same side as injection) 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 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced HYPOAESTHESIA (slight numbness in my left cheek-same side as injection). At the time of the report, HYPOAESTHESIA (slight numbness in my left cheek-same side as injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  No Treatment medications were reported.
Information was received from a Certified Medical Assistant, regarding a 44 year old female patient, with an unknown vaccination history and with allergy to OMNICEF-unspecified reaction, asthma, high blood pressure, high cholesterol, iron deficiency, and prothrombin gene mutation. On 26-JUL-2013, the patient had a hepatitis B surface antibody titer drawn with an unspecified "negative" result. The patient was vaccinated with RECOMBIVAX HB, Lot # H017018 (exp. 11-JUL-2015) 0.5 ml, intramuscular on 02-AUG-2013. Concomitant therapies included: WELCHOL, QVAR, furosemide (manufacturer unknown), FLONASE, PROVENTIL, benazepril HCL and sertraline hydrochloride (manufacturer unknown). Another hepatitis B surface antibody titer was drawn on 30-SEP-2013 and was reported as negative with a result of "less than 5 miu/ml". The outcome of hepatitis B surface antibody titer negative is unknown. Additional information has been requested.
T 00:30 on 6-10-09 c/o headache then at 01:00 c/o "whole body shaking" last 1/2 hour then c/o "heaviness in the legs ". Ran low grade fever x 4days. No treatment. Seen by PMD.
Patient received Pneumovax 23 on the left deltoid on Nov 10, 2020. He complaints that his left arm is soar when he raises his arm and symptom developed ever since he got the immunization. Checked his arm today. There was no sign of redness, swelling, infection.
Moderna COVID-19 Vaccine EUA Some facial swelling (no throat swelling)  starting about 30 minutes after the shot.  Swelling started to decrease after about an hour  (1.5 to 2 hours after the shot), with some feeling of residual swelling for several hours.
patient was administered with expired TENIVAC with no adverse event; Initial information received on 27-Sep-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 53 years old male patient who was administered with expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Sep-2023, the patient was administered with expired standard dose of 0.5 ml total of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot U7183AA, expiry date- 24-SEP-2023) via intramuscular route in the deltoid NOS (not otherwise specified) for Immunization with no adverse event (expired product administered) (latency- same day).   Reportedly, Nurse asks for recommendations on safety and re-vaccination following administration of tenivac.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
I had three Pfizer Covid vaccinations; currently fighting Covid; currently fighting Covid; severe asthma; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; influenza vaccine (FLU) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "I had three Pfizer Covid vaccinations"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "currently fighting Covid"; ASTHMA (non-serious), outcome "unknown", described as "severe asthma". The events "currently fighting covid" and "severe asthma" were evaluated at the physician office visit.  Clinical course: Patient had received three Pfizer Covid vaccinations and the flu one as well and currently fighting with Covid and severe asthma. Her doctor recommended Paxlovid (nirmatrelvir and ritonavir tablets), but there were no pharmacies in her area carrying this antiviral drug.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a physician concerning a female who on approximately 19-NOV-2007 was vaccinated with her first dose of Gardasil vaccine. Approximately 2 days after administration, the patient developed hives. The patient was examined in the office. The patient fully recovered from hives without requiring treatment. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007. Follow-up information was received from a mother concerning her 20 year old daughter with no pertinent medical history and has a drug allergy to amoxicillin who on 20-NOV-2007 was vaccinated with a first dose of GARDASIL vaccine (lot# unknown). Concomitant therapy on 20-NOV-2007 included a tuberculin test (unspecified). On 20-NOV-2007 * her daughter broke out with hives after receiving her first dose of GARDASIL vaccine. No further information given. Additional information has been requested.
Headache, Myalgia, Diarrhea, left arm sore Narrative:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-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), in right arm 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: "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. Paxlovid treatment start date: 13Jul2023, stop date=17Jul2023.   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.
Soreness at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included LEVONORGESTREL (MIRENA) from 01-Jan-2019 to an unknown date for Birth control.    On 06-Jan-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021 at 4:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2021, Activated partial thromboplastin time: 25.4, 25.3 Second (Low) aPTT 25.4, 25.3. On 25-May-2021, Antiphospholipid antibodies: not detected (Inconclusive) Lupus anticoagulant qual Not detected. On 25-May-2021, Antithrombin III: 124 (Inconclusive) Antithrombin III activity % 124. On 25-May-2021, Coagulation factor VII level: 55 (Inconclusive) Factor VII activity clotting % 55. On 25-May-2021, Protein C: 146 (High) Protein S Activity% 146(H). On 25-May-2021, Protein S: 127 (High) Protein S Activity% 127(H). On 25-May-2021, Prothrombin time: 9.5 Second (High) PT sec 9.5, 9.5 INR 0.9. On 25-May-2021, Russell's viper venom time: 26.9 Second (Inconclusive) Dilute Russell viper venom time 26.9 sec.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication details provided.   This case was linked to MOD-2021-168832 (Patient Link).
Case number PHEH2015US019857, is an initial spontaneous report received from a pharmacist on 02 OCT 2015. This report refers to a 60 year old female patient. Historical and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN 2015/2016 (batch number: 1514801) intramuscularly at a dose of 0.5 ml on 02 OCT 2015. The pharmacist reported that the vaccine FLUVIRIN that had reached 52 degree for 30 minutes was administered to the patient. No adverse event was reported following the medication error (incorrect storage of drug).
Patient received incorrect 2nd Pfizer vaccine. Patient received 1st dose Moderna on 9/17/21. Patient received Pfizer dose on 10/08/21. Discussed with provider, no additional recommendations noted. Patient did not exhibit any adverse reactions during 15 minutes after injection. Left message for patient to return call to inform of manufacturer mismatch.
I can bear no weight on my left leg without excruciating pain in the joint behind my knee cap. It is unbearable and no one will call me back. This is awful. No one from VAERS will pick up the phone and I need to know what to do. This is so irresponsible.
Pt recvd 3 Hep B vax given 25JUL89, 31AUG89, & 25JAN90; 19MAR90 titer=12; 8MAR91 titer=2; Pt was given a 4th dose of Engerix-B vax on 2MAY91; 12AUG91 titer=77;
Low fever for two days, strong muscle aches, chills. Took ibuprofen OTC and helped.
sinking sense of doom-death; high heart rate; BP is spiking to 165/100; mile fever; sore arm; Severe headache; blood sugar spikes of 200 fasting; Increased tahcycardiaI suffer from that) but it was more frequent and severe; chest pains; This is a spontaneous report received from a contactable consumer (patient) reported for herself.  A 56-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM6199) via an unspecified route of administration, administered in Arm Left on 10Mar2021 at 12:00 at a single dose for covid-19 immunisation. Medical history included had covid from 30Jun2020. Concomitant medication patient received within 2 weeks of vaccination included Metoprolol ER 25 mg cyclic, Armour Thyroid 30 mg cyclic. The patient previously took fluoroquinolones and experienced known allergies. The patient reported that on 13Mar2021 on Day 3 of vaccine BP starts to go up. My average is 100/50.  By day 4 BP is spiking to 165/100 with a mile fever and sore arm, and a sinking sense of doom-death). Severe headache and continued blood pressure spikes throughout week along with blood sugar spikes of 200 fasting. I'm not diabetic. Increased tahcycardiaI suffer from that) but it was more frequent and severe.  Blood pressure spiked to 187/167, I took extra BP meds (which was low dose more for my tachycardia)to help with insane BP. Went to hospital and stayed for 2 days. No heart attack, Just insane BP with chest pains and high heart rate. Day 18 after shot and BP is going down and so is blood sugar. Every once in a while, it will spike to 160/100--last for about 1 hour and then drop to my normal BP before the shot. The events were considered serious with seriousness criteria hospitalization and medically significant. The patient was hospitalized for 2 days. Adverse events resulted in Emergency room/department or urgent care, Hospitalization. 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. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the adverse event. The patient underwent lab tests and procedures which included Nasal Swab: negative on 23Mar2021. The patient was recovering from all the events.  Follow up needed, further information has been requested.
This spontaneous report was received from a licensed practical nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On multiple unknown dates, the patients were vaccinated with improperly stored doses of VAQTA for prophylaxis, (route, dose, lot# and expiration dates were not reported). No adverse effects were reported. There were no previous temperature excursions; the data logger reported: "traceable Min. and Max." There was no Product Quality Complain (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA012322: US-009507513-1612USA013204: US-009507513-1612USA013206: US-009507513-1612USA013207:
rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) 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 RASH (rash). At the time of the report, RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided.   Reporter did not allow further contact
Patient came into the office after waiting for approx 30 minutes after covid vaccine. She said she noticed that her mouth and lips felt slightly swollen and tingly. After speaking with patient she gave the following reaction.   5 minutes after receiving the vaccine she noticed tingling in her hands that last about 1 minute.    30 minutes after while in the car (patient had labs drawn while waiting) she felt slight puffiness in her lips and lower face along with tingling. She then came back into the office.    Patient was negative for headache, dizziness, nausea, blurred vision. Blood pressure was checked @ 11:50 and was reading 178/104 manual. Patient was given water and escorted to a room to wait.    12:00 BP: 168/73- patient reports the facial tightness and tingling are getting a little better.    12:10 162/80- patient reports tingling is now almost gone, still no other complaints.    Patient was evaluated by Dr and told since her BP was coming down and she was feeling better, she could go home. I recommended to patient to stay out of work today and take a benadryl. Dr gave same instructions and wrote a work note for patient.    I encouraged patient to call with any further problems or concerns.
Red rash warm to the touch for 48 hours .  Ache in joints for about 3 weeks.  Fatigue for 4 weeks and counting.  Has interfered with normal activities since Jan 9th.