chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Contracted Shingles 2 days after vaccine in left armpit; Experienced whole body aches 1 day after vaccine; pain in back felt like a charlie horse; had back pain in between left shoulder blade and spin/ Pain in back got worse; This is a spontaneous report from a contactable consumer (patient) via Covid-19 Adverse Event Self-Reporting Solution (COVAES ). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 19Mar2021 at 15:45 (lot number: EN6208; expiry date: unknown) as dose 1, single, for COVID-19 immunization. The patient had no relevant medical history. The patient had no allergies to medications, food, or other products.The patient was not diagnosed with COVID prior vaccination. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The vaccine was administered in the hospital. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient did not receive other medications within two weeks of vaccination. On 20Mar2021 (1 day after vaccine), at 12:00, the patient experienced whole body aches, back pain in between left shoulder blade and spine, pain in back got worse; whole body aches subsided. Pain in back felt like a Charlie horse for 5 days.  She couldn't get out of bed; she was in extreme pain. On 21Mar2021, 2 days after vaccine, the patient contracted shingles in left armpit. Dr. stated that pain in back was connected to shingles. Patient was put on steroids and nerve blockers then pain subsided. Patient took antivirals (Valtrex) for shingles. Shingles rash subsiding. The events resulted to doctor or other healthcare professional office/clinic visit as well as Emergency room/department or urgent care. The events were considered serious, medically significant. Outcome of the event shingles was recovering, while for the other events was recovered on unspecified date in 2021. The patient has not been tested for COVID-19 since vaccination.
This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown age and gender. In May and June 2017, the patients were vaccinated with VAQTA for prophylaxis. In May and June 2017, the patients experienced incorrect product storage. On an unknown date, the patients experienced no adverse event. It has been determined that lot # M027829 in not valid for VAQTA. This is one of 3 reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA009379: US-009507513-1708USA009480:
Pt had been lethargic, decreased appetite. Bright red rash on cheeks and face. Rash on legs, had slight rash prior to administration on legs now more red and spreading.
Positive COVID PCR test; This is a spontaneous report from a contactable consumer (patient's wife). A 58-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9264), via an unspecified route of administration in right arm on 29Jan2021 16:00 at single dose for covid-19 immunization. Medical history included ongoing type 2 diabetes, they believe he contracted Covid at that inoculation from unknown date and unknown if ongoing. There were no concomitant medications. Family medical history included: Diabetes. The patient experienced positive covid PCR test on 03Feb2021. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. The caller stated she was calling on behalf of her husband who received his first dose of the vaccine on 29Jan2021. They believe he contracted Covid at that inoculation. The caller asked if he should receive his second dose of the vaccine. Her husband 100% thinks he contracted it at the vaccine clinic and does not want to go back. She stated they read an article that they are finding folks who had Covid only need on dose of the vaccine. She stated this was an article from 01Feb titled "Had Covid, You May Need Only One Vaccine, Study Suggests" from (id). Caller's husband, the patient, received the Pfizer vaccine on 29Jan2021. There was no social distancing and other things occurred at the clinic he was. Patient ended up contracting COVID. Asked if patient needs second dose. Is scheduled for second dose on 19Feb2021. Started feeling symptoms on Wednesday, 03Feb2021. Had a positive COVID PCR test. Vaccination Facility Type: Hospital. No additional vaccines administered on same date of Pfizer suspect. No prior vaccinations within 4 weeks. No adverse events follow prior vaccinations. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 03Feb2021. The outcome of event was unknown.
This spontaneous report as received from a pharmacist refers to two patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 10-DEC-2015, the patients were inadvertently vaccinated with expired doses of MMRII (lot # J014872, expiry date 21-NOV-2015; dose and route were not reported). No adverse effects were reported. Additional information has been requested.
got a mild case of the flu after the shot; Initial information received on 16-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves female patient (age not reported) who got a mild case of the flu (influenza), while she received vaccine INFLUENZA VACCINE.  The patient's past vaccination included Influenza vaccine.  The patient's past medical history, medical treatment and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route in unknown administration site prophylactic vaccination.  On an unknown date, the patient who got a mild case of the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
within hours after vaccine - noted left arm pain and reduced range of motion, reduced ability to push/pull with left arm - sxs still present 2 months later
Patient came with parent to received booster Pfize vaccine. The consent form was handed in to the pharmacy technician and I went out to give the vaccination. Before giving the vaccine I asked patient to verify DOB and her age and she confirmed she was 16 years old, but she is 15 years old.
FEELING HAZY; RAISED BUMP AT INJECTION SITE; HEADACHE; WATER BLISTERS UNDER NOSE AND TURNED INTO SORES ON UPPER LIP AND UNDER LEFT NOSTRIL AND COMING DOWN TO LIP; FELT HORRIBLE; DISORIENTATED; DIZZINESS; SHORTNESS OF BREATH; TIREDNESS; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21/06/2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced tiredness. On 26-MAY-2021, the subject experienced water blisters under nose and turned into sores on upper lip and under left nostril and coming down to lip. On 26-MAY-2021, the subject experienced felt horrible. On 26-MAY-2021, the subject experienced disorientated. On 26-MAY-2021, the subject experienced dizziness. On 26-MAY-2021, the subject experienced shortness of breath. On 26-MAY-2021, the subject experienced raised bump at injection site. On 26-MAY-2021, the subject experienced headache. On 28-MAY-2021, the subject experienced feeling hazy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt horrible, disorientated, dizziness, tiredness, and headache, had not recovered from water blisters under nose and turned into sores on upper lip and under left nostril and coming down to lip, raised bump at injection site, and shortness of breath, and the outcome of feeling hazy was not reported. This report was non-serious.
Within 24 hrs of vaccination: Achiness, chills, low grade fever (documented T 100.1 oral). Headache, stiffness in back and neck, GE reflux. Lasted 36 hrs despite NSAID. Also (B) swollen, tender muscles & erythema at injection sites - (very large on Rt). Had to miss work on 8/6/10.
Migraine; Tiredness; This spontaneous case was reported by a physician and describes the occurrence of MIGRAINE (Migraine) and FATIGUE (Tiredness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine) and FATIGUE (Tiredness). At the time of the report, MIGRAINE (Migraine) and FATIGUE (Tiredness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
Arm became red, swollen, and sore at injection site. 6x5cm with induration lasting 4-5 days.
I had the shot /still got/ Shingles/suspected vaccination failure; bad case of Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received shingle shot and still got shingles. The patient stated that according to her/his doctor it was a bad case of Shingles. The follow up would not be possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and time to onset and laboratory confirmation for shingles were unknown.
Approximately 8 hours following the 2nd dose of Shingrix Patient experienced chills, shivering and myalgia. These symptoms lasted approximately 8 hours and were relieved with APAP and IBUPROFEN.
25 hours after receiving Covid vaccine, patient began seizing and went into cardiac arrest. Daughter began CPR and continued until EMS arrived. Patient subsequently passed away at Hospital.
Complained of feeling slightly lightheadedness, feeling odd, as if her mind & body were disconnected. She was perspiring, chills. 11:10 AM-She felt a lump in her throat. Dr. ordered Benadryl. 11:15 am Benadryl given with water. V/S-T98.7 115/76 b/p- 11:25 Feeling tired and rested. 11:45-Lump in her throat was gone. 11:55-Felt fine except her legs felt like a jello & resumed work at the computer.
5 days after receiving the COVID booster patient had reactivation of HSV1 viral lesions in the genital area. Last and only outbreak was 6 years ago. Multiple lesions (4). No other side effects.
Dizziness, Headache, NauseaVomiting, "states that for 3 days right after the vaccine she had nausea, dizziness, headache which have subsided. Then developed swollen lymph nodes in her rt groin on 3/9 which resolved and then on 3/11 noticed a few small enlarged lymph nodes in the right axi Narrative: As documented on 3/19/2021: ********************************** "Did you recover completely from event? NO--ongoing at this time Any past history of adverse drug reactions? yes to sulfa drugs if yes, age at the time and description of vaccine and description of event? had anaphylaxis reaction Advised if no improvements or worsening of symptoms to seek urgent/emergent care or contact primary care provider for further evaluation."
No known patient adverse reactions or side effects; 1 dose of ROTATEQ was administered on 7/13/22 /  temperature excursion; This spontaneous report was received from an Office Manager/Vaccine Coordinator referring to a 12-week-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  The Office Manager/Vaccine Coordinator reported that there was a temperature excursion just discovered, it occurred between 11-JUL-2022 and 15-JUL-2022. Vaccines involved in the excursion were Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Captured in case # 2208USA003021). The vaccine undergo a temperature excursion of above 47 degrees Fahrenheit (F) (55.2F) for a period of 5 hours, and above 47 degrees Fahrenheit (F) (53F) for a period of 30 minutes (Product storage error). The vaccine did not underwent a previous temperature excursion.  On 13-JUL-2022, the patient was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2ml by mouth, administered as prophylaxis, lot number was verified to be U038864 with expiration date of 22-APR-2023. There were no known patient adverse reactions or side effects (No adverse event).   An excursion on 26-JUL-2022 was already reported.  This was one of two cases from the same reporter.; Sender's Comments:  US-009507513-2208USA003021:
5 doses administered from vials that underwent a temperature excursion/3 doses administered from vials that underwent a temperature excursion; No Adverse event; 3 doses administered from vials that underwent a temperature excursion/5 doses administered from vials that underwent a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses administered from vials that underwent a temperature excursion/3 doses administered from vials that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion/5 doses administered from vials that underwent a temperature excursion) and NO ADVERSE EVENT (No Adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion/5 doses administered from vials that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses administered from vials that underwent a temperature excursion/3 doses administered from vials that underwent a temperature excursion) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses administered from vials that underwent a temperature excursion/3 doses administered from vials that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion/5 doses administered from vials that underwent a temperature excursion) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses administered from vials that underwent a temperature excursion/3 doses administered from vials that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion/5 doses administered from vials that underwent a temperature excursion).    Concomitant medication information was not provided by the reporter.  No vaccines in this lot have been administered since the temperature excursion.  Treatment information was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-654338 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654338:same reporter
Patient is here today for personal appointment. It was noted by EMS that he was complaining of chest pain / pressure and experiencing shortness of breath / difficulty breathing per patient report.  At 1625, call placed to outside EMS.  History of: depression, obesity, history of stress-induced cardiomyopathy  Nursing Assessment:  Airway: Open Breathing: Spontaneous Circulation: Pulse present Mentation: Alert Skin: Normal  Patient monitored. and Oxygen saturation level obtained.   Patient complained of feeling disorientated after first dose of vaccine. After second dose patient complained of feeling tightness in his chest, some shortness of breath, and an itch in his throat. Patient on EMS monitor with a HR of 90 and oxygen saturation of 100%. EMS offered patient IV Benadryl which patient refused. EMS activated outside EMS service and was taken to ER. Patient agreed to plan of care   He was transported to the emergency department via ambulance at 1635.
her arm hurt with the previous doses too; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 83-year-old female patient received bnt162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "anxiety attack", "mild fatigue", "her arm hurt with the previous doses too"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "her arm hurt with the previous doses too"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "her arm hurt with the previous doses too". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm hurt with the previous doses too".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300348067 Same patient, different vaccine dose number, different AE;
2 days after 2nd shot, I couldn't walk or use my right leg. Days later, soreness spread to my arms, neck and hands
lt deltoid swollen @ sore;cold packs & APAP advised;f/u if worsens;
w/in 5 mins p/blood test & IM  pt became weak & dizzy; returned to room & table w/legs elevated; Monitored for 15 mins; pt was ok & left office;
This spontaneous report has been received from a 42 year old non-pregnant female pharmacist who was also the patient, reporting on herself. The patient had no pertinent medical history, drug reactions or allergies, or concomitant medication. The patient stated that on 11-OCT-2017 she got a few drops of ZOSTAVAX (lot number N022036 and expiration date on 11-NOV-2018) in her eye. The patient did not sought medical attention. It was reported that she rinsed her eye out and then she stated that she was fine; therefore the outcome of the event was reported as recovered at the time of reporting. No adverse effects were reported.
11/13/2021 approximately 10:00 AM--symptoms wave 1: dizzy, light headed, weak, sweating and light nausea; approximately 10:30 AM wave 2 symptoms: blacked out (less than 10 minutes), hit on forehead (swelling, scratches and minor cuts on forehead and nose; glasses caused both areas around eyes to blacken and swell).
fever to 102-6 hrs p/inject, fuzzy, tender lt thigh (site of inject);
Aching; Shaking; Chills; Throwing up; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Apr2021 at 13:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included clotrimazole (LOTRIMIN) from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 30Apr2021 at 02:00, the patient experienced chills, shaking, throwing up, aching and weakness. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of events chills, shaking, throwing up, aching and weakness were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Lymph Nodes in armpits; COVID-19 vaccine was administered on the same date as the other vaccine; This is a spontaneous report from a contactable consumer (patient himself). A 74-year-old male patient receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on the right arm on 17Jan2021 at 07:45 at a single dose for COVID-19 immunization. The first dose of another vaccine (unspecified trade name; reported product: "Phizer," lot number and expiration date were unknown) was also administered on the same date on 17Jan2021, via an unspecified route of administration on the left arm at unknown dosage and frequency for an unspecified indication. The facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient's medical history was not reported. Concomitant medication included morniflumate (FLOMAX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Jan2021 at 07:45, the patient experienced lymph nodes in armpits, which was considered as non-serious. COVID-19 vaccine was administered on the same date as the other vaccine on 17Jan2021. The patient did not receive any treatment for the adverse event "lymph nodes in armpits." The patient was not recovered from the event lymph nodes in armpits.  Information on the lot/batch number has been requested.