chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had Pfizer vaccine and boosters / tested positive for COVID/ prescribed Paxlovid; had Pfizer vaccine and boosters / tested positive for Covid / prescribed Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 22Dec2022, outcome "unknown", described as "had Pfizer vaccine and boosters / tested positive for COVID/ prescribed Paxlovid"; COVID-19 (medically significant) with onset 22Dec2022, outcome "unknown", described as "had Pfizer vaccine and boosters / tested positive for Covid / prescribed Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Dec2022) Positive; (31Dec2022) Negative; (02Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil (lot number unknown) injection. The physician reported that the patient fainted after receiving Gardasil. Medical attention was sought. No further information was provided. Additional information has been requested.
received 2 doses on 23Mar2022; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 2-year-old male patient who received HAV (Havrix) (batch number 4CY9H, expiry date 28th April 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 23rd March 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 23rd March 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter reported that a patient accidentally received 2 doses of Havrix on the day of reporting, which led to accidental overdose. No symptoms were reported. The reporter consented to follow up via email.
(Note: I am estimating at date of 2nd vaccine.) I experienced itchy hives off and on for about a month - that was located under my armpit on both arms It went away. And then in the last month and 1/2 to two months ago, more recently,  I have had a itchy red, bumpy rash - vertical in length - under both arms - underneath sides of the upper arms. I thought initially it was a reaction to a product. My nurse practitioner looked at it and she said to put Hydrocortisone cream - OTC on it. It didn't quite clear up and eliminating products didn't clear it up. I called the doctor and she called in a prescriptions for a Hydrocortisone with a steroid on it. I have been on that for about a month. I have used it off and on during the month because sometimes I notice the rash more so than other times. It does help some but then it kind of comes back at different times. It hasn't completely healed it up. Keeps coming back.
Fever peaked at 101 on Sunday. Patient felt horrible on Sunday May 13th and took some TYLENOL and stayed in bed. Site of injection extremely red and irritated. By Monday morning May 14th patient felt much better although arm was still red at site.
Initial information received on 18-Feb-2019 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 23 months old female patient who was vaccinated with a dose of TYPHIM VI (lot P1D701M and Exp. Date 15-Sep-2020) on 16-Feb-2019 via an unknown route in unknown site. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to inappropriate age at vaccine administration. It was unknown whether the patient had any adverse reactions. 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 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. List of documents held by sender: none.
Information has been received from a consumer concerning her currently 14 year old niece who as a toddler was vaccinated with a dose of MMRII. Consumer reported that she became a "different child" one month after her vaccination when she was a toddler. She became a "space child", stared into space and has been diagnosed with mild autism. Upon internal review autism was determined to be an other important medical event. Additional information has been requested.
Swelling and redness started on 10/8/15 in 7:30 getting bigger now 11.0 cm  longest x 9.8 cm width. (+) pain. WBC - 8.1. Treat with AUGMENTIN for infection. Defer on ROCEPHIN for now. to follow by phone tomorrow. BENADRYL.
She said her left arm was throbbing in pain after the vaccine and her left side up to her neck also in pain. She had severe headache, could not move her body due to the soreness. I did not see any redness or swelling at injection site.
hasn't gotten the second dose yet.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2017). Concurrent medical conditions included als.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient.  The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The patient spoke per personal information and referred to healthcare professional. No healthcare professional information was provided. The reporter did not consent to follow up.
About 5 hours after my initial injection I began experiencing a headache. It continued to increase until a full-blown migraine ensued. It kept me up most of the night and was then compounded by nausea, and aches. The symptoms continued to increase and I was in bed from Thursday evening until this morning. I began vomiting on Friday, although it subsided. I continue to experience low energy, although the headache and nausea have finally abated.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 in 01/2023. I found out I was positive five days after m symptoms started so I did not contact my doctor.  I took over the counter medication to help with my symptoms. As of today, I still have the fatigue that I never feel rested. My sleep habits have changed too. I wake up and have difficulty going back to sleep.
Clients mother states 105 temp 1 day after receiving vaccines. Client taken to ER. Tx and released same day. (VAE not reported until 10-14-09).
flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 30-Nov-2020.  This case involves a patient of an unknown demographics who experienced flu (influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced flu (influenza), (unknown latency) following the shot of INFLUENZA VACCINE.   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Mentioned she did not have an allergic reaction, but her sister did to the first dose; This is a spontaneous report from a contactable consumer [patient's sister].  A female patient [reporter's sister] of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine; Solution for injection; lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On an unspecified date after first dose of vaccination patient experienced allergy. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
14-Oct-21 into refrigerator and never opened before today; expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) and PRODUCT STORAGE ERROR (14-Oct-21 into refrigerator and never opened before today) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (14-Oct-21 into refrigerator and never opened before today). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved. At the time of the report, PRODUCT STORAGE ERROR (14-Oct-21 into refrigerator and never opened before today) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Mom called clinic 3/7/07 reporting adverse reaction occurred 3/6/07 at 3:30 pm sleep, achy, lethargic. Slept all afternoon did not eat. Awoke 3/7/07 suddenly pointing to unknown object asking for "someone to give me that" repeatedly. Then, stiffened arms by her side whole body stiff per mom for approximately 3 min. Afterward unaware of what was happening and lethargic. No fever, no other symptoms reported. Episode occurred only once, mom instructed to take child to physician or ER.
Patient received  Pfizer monovalent primary series (5-11Yrs) second dose.
Her eyes being itchy; Eye tearing; Her eyes being red; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 02Feb2021, as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication taken 2 weeks after the first dose included varicella zoster vaccine rge (cho) (SHINGRIX) from Jan2021, taken for an unspecified indication, stop date was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 12Jan2021, as single dose for COVID-19 immunization. On an unspecified date in Feb2021, the patient's eyes were being itchy and red; and had eye tearing since the second shot. The patient was prescribed with eye drops. The clinical outcome of the events was reported as not resolved.  Information on the lot/batch number has been requested.
8/21/2010 12:00 PM - Soreness at injection site, bodyaches, fever, chills, headache, fatigue - lasted til 8/23/2010 in early am hours. Cough onset 8/23/2010 in AM until present.
as per MD notation, :"Patient is a 36 Yo female had her first Moderna CoVid vaccine on    1/29/21 and on the 3rd of February, 5 days later, developed a delay    hypersensitivity reaction in the left upper arm with warmth to the    touch, redness and some axillary painful lymphadenopathy that is    causing pain along the left later breast.  Patient is rated at 6/10 and    arm is very warn to the touch.  I ordered ibuprofen to use q 6 H with    food over the weekend. advise cold packs to the upper deltoid of the    left arm, start cetirizine today asap and go home and rest. Epi pen was    also dispensed.  Pretreatment with cetirizine and ibuprofen advised    prior to moderna #2 vaccine. "
Information was received from an unspecified health professional regarding a patient (demographics unknown), who on unknown date, was vaccinated with VARIVAX (Merck) lot # J003221, expiration date 15-MAR-2015, which had been improperly stored. The outcome of the improperly stored vaccination was unknown. Follow up information has been received from a nurse who called and stated all patients (who received VARIVAX (Merck) that was exposed to unknown temperatures for 4 hours) had been revaccinated. No symptoms reported. This is one of several reports received from the same source (linked MARRS#:1311USA000056, 1310USA014891, 1310USA014881, 1310USA014883, 1310USA014888, 1310USA015417, 1311USA000071, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014866, 1310USA014868, 1310USA015422, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064, 1311USA000021, 1311USA000020, 1311USA000022, 1310USA015101, 1310USA014853, 1311USA000075, 1310USA014895, 1310USA015119, 1310USA015113, 1311USA000059, 1311USA004931, 1311USA000065, 1311USA000739, 1311USA000040, 1310USA015096, 1311USA000642, 1310USA014958, 1311USA000072, 1310USA015127, 1311USA000053, 1311USA000085, 1311USA000741, 1311USA000744, 1310USA015134, 1311USA000083, 1310USA015141, 1311USA000006, 1311USA000005, 1310USA014900, 1310USA015268, 1310USA015264, 1310USA014896, 1310USA014909, 1311USA000627, 1310USA015396, 1310USA015270, 1311USA000637, 1310USA014962, 1311USA000039, 1311USA000037, 1311USA000032, 1311USA000002, 1310USA014897, 1309USA011086). Additional information is not expected.
Immmediate local swelling of the upper right arm surrounding the injection. (hep A) no bruising, no problems breathing, no pain except when ice applied, and patient watched in off ice for ~ 30 minutes. Swelling still present at discharge. 6:30 PM swelling is done. he acted normally and much less swollen.
This spontaneous report was received from a medical assistant regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, unspecified patients were administered with improperly stored PNEUMOVAX 23 lot# M042785, and expiry date: 17-JUN-2018 for prophylaxis (dosing details were not reported). Temperature was reported as 51.6 F and time frame was 2 hours 20 minutes. There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports due to the same reporter. Additional information has been requested.
1ST DOSE: 4-5 D AFTER SWALLEN WITH LIMITED ROM ALSO SHOULDERS SLEEPY - ALL RESOLVED IN ABOUT 10 DAYS 2ND DOSE: SAME SX AS AFTER THE 1ST DOSE, BUT MORE SEVERE, MORE JOINTS AND BACK STIFF - IMPROVING BUT NOT COMPLETELY RESOLVED IN 10 DAYS
Fever,  Sever body aches and chills, sever fatigue and severs headache
Information has been received from a health professional concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil injection. Concomitant therapy included MENACTRA. Subsequently the patient fainted. Unspecified medical attention was sought. At the time of reporting it was unknown if the patient had recovered. No further information was provided this adverse experience. Additional information has been requested. This is one of several reports from the same source.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates the patients were vaccinated with improperly stored VARIVAX (lot # L008273, expiration date 11-MAR-2017, dose and route unspecified). No adverse effects were reported. It was reported that the vaccines were stored at 11 F for 3360 hours. Additional information has been requested.
received the first dose of the Pfizer covid vaccine and before he was suppose to get his second dose on 25Feb2021, he tested positive for covid.; received the first dose of the Pfizer covid vaccine and before he was suppose to get his second dose on 25Feb2021, he tested positive for covid.; This is a spontaneous report from a contactable nurse. An 85-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  Patient received the first dose of the Pfizer covid vaccine and before he was suppose to get his second dose on 25Feb2021, he tested positive for covid. He received the monoclonal antibodies and caller wanted to know if  monoclonal antibodies could attenuate the first dose of the Pfizer covid vaccine. The outcome of the events was unknown.  Information about lot and batch number was requested.; Sender's Comments: A causal relationship between  BNT162B2  and the reported events cannot be excluded based on temporal association.
Patient was given Pediarix and Hep B  on same day instead of Pediarix and Hib. There were no adverse events
COVID 19; COVID 19; Pfizer, Administration date: 01Oct2021/Moderna, Administration date: 15Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), on 01Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) and on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Apr2022, outcome "unknown", described as "Pfizer, Administration date: 01Oct2021/Moderna, Administration date: 15Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included PAXLOVID from 21May2023 to 26May2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
3mins post vaccination pt had an episode of vomiting, flushing, and sweating. Vitals: 98/52, 93, 20, 100% Temp 97.8 -- > 105/56, 94, 20, 100% Pt stable and released from the vaccination site 25mins post vaccination.
HOSPITALIZATION AND DEATH RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY COVID VACCINE SERIES
I woke up one morning, and I could barely move. I had severe pain in my shoulder, hips, hands, and wrist. I couldn't close my hands or fist. My hands were very weak. By the middle of the day it had eased up, and I was able to function again. This continued every morning. I went to see my doctor. They said my inflammation levels were high. My doctor put me on a 5 day course of prednisone 40mg 1xday. That medication helped a lot, but when I stopped taking it everything came back. This had continued. Then my doctor put me on a daily does of Prednisone 15mg. I'm taking it now and it has helped but not completely. My doctor thinks I may have polymyalgia rheumatica.
Bump and rash on left arm at injection site 1 week after injection. After 1.5 days, lump went away but rash remained. Still have a rash after 2 days. No itching or pain.
This spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored ROTATEQ lot # M016918, expiration date: 15-FEB-2018, given orally, RECOMBIVAX HB lot # M033334, expiration date:11-AUG-2018 given via intramuscular injection, GARDASIL 9 lot # L037554, expiration date: 25-DEC-2017 given via intramuscular injection, and VAQTA lot # M036459, expiration date: 18-JAN-2018 given via intramuscular injection (strength, dosage, and anatomical location were not reported). Concomitant medications were not provided. No adverse effects reported. Excursion information below: ROTATEQ lot # M016918, expiration date: 15-FEB-2018, RECOMBIVAX HB lot # M033334, expiration date:11-AUG-2018, GARDASIL 9 lot # L037554, expiration date: 25-DEC-2017, and VAQTA lot # M036459, expiration date: 18-JAN-2018 .Temperature: 34F;Time frame: 8 Hours and 18 Minutes.There were no previous temperature excursion and the call was because of a data logger. Additional information has been requested.