chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administrated / after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 11-month-old male patient who received HAV (Havrix) (batch number yl532, expiry date 9th September 2022) for prophylaxis.   On 19th July 2021, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: The physician reported that a male patient was administered with Havrix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case is one of 28 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779: US-GLAXOSMITHKLINE-US2021164800: US-GLAXOSMITHKLINE-US2021164784: US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164801: US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164789: US-GLAXOSMITHKLINE-US2021164786:Same reporter. US-GLAXOSMITHKLINE-US2021164793:Same reporter. US-GLAXOSMITHKLINE-US2021164794:Same reporter. US-GLAXOSMITHKLINE-US2021164797:Same reporter. US-GLAXOSMITHKLINE-US2021164798:Same reporter. US-GLAXOSMITHKLINE-US2021164799:Same reporter. US-GLAXOSMITHKLINE-US2021164804:Same reporter. US-GLAXOSMITHKLINE-US2021164805:Same reporter. US-GLAXOSMITHKLINE-US2021164806:Same reporter. US-GLAXOSMITHKLINE-US2021164808:Same reporter. US-GLAXOSMITHKLINE-US2021164793:same reporter
Tested positive with antigen on 05Jun2022; Tested positive with antigen on 05Jun2022; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 11Jan2021 as dose 2, single (Lot number: EK9231), in left arm and on 30Aug2021 as dose 3 (booster), single (Lot number: EW0186) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 09Feb2022 as dose 4 (booster), single (Lot number: 070H21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seronegative rheumatoid arthritis" (unspecified if ongoing); "perennial allergic rhinitis" (unspecified if ongoing); "depression" (unspecified if ongoing); "Dose:4 Moderna/Dose:1, 2 and 3 Pfizer" (unspecified if ongoing), notes: Dose:4 Moderna/Dose:1, 2 and 3 Pfizer. Concomitant medication(s) included: METHOTREXATE, start date: Apr2020, stop date: 29May2022; LEXAPRO, start date: Feb2019, stop date: 15Jun2022; HUMIRA, start date: Jun2020, stop date: 14Jun2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: Jan1995, stop date: 15Jun2022; FOLIC ACID, start date: Apr2020, stop date: 15Jun2022. Past drug history included: Zosyn, reaction(s): "Known allergies: Zosyn", notes: Known allergies: Zosyn. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 05Jun2022, outcome "not recovered" and all described as "Tested positive with antigen on 05Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive, notes: Tested positive with antigen on 5Jun2022; (11Jun2022) Negative, notes: Tested negative antigen on 11Jun2022; (15Jun2022) Positive, notes: positive antigen test 15Jun2022. Therapeutic measures were taken as a result of covid-19, vaccination failure.; Sender's Comments: Based on the information in the case report, a causal association between reported events and suspect BNT162B2 is possible.
This spontaneous report as received from a pharmacist refers to a over 60 year old female patient. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot # J004196, Expiration Date: 06-DEC-2014) injection intramuscular. Concomitant medication was unspecified by the reporter. On an unknown date, (reported as one women) few days after the vaccination, the patients experienced the entire arm from elbow to injection site was red and they felt absolutely terrible. No treatment was given. Patient sought medical attention reported as went to pharmacy. No Product quality complaint. It was unclear if patients had ever had PNEUMOVAX23 injection before. Outcome of the reported events was unknown. Causality of the reported events was unknown (not provided). This case is related to 1312USA009845 and 1312USA009850 (Same Reporter Link). Additional information has been requested.
Nausea, fever, extreme body aches, chills, extreme fatigue - duration 6 hours.  Stomach upset/diarrhea, fatigue- duration 4 days.
8NOV tired, no temp, h/a, coughing, drainage from throat, put on ATBs; 30NOV still having headaches & no energy;
In late November 2022, my eyes felt sandy, and my throat began to hurt. I tested positive for COVID-19 on November 26, 2023. I took TYLENOL and zinc. I contacted my doctor, and I began remdesivir infusions on the November 29th. The next day during my infusion I had a vasovagal reaction and went to the emergency department. I was able to get my second infusion in the ED. The third infusion was successful. They were able to give me the infusion there. I had a follow-up doctor's appointment on December 5, 2022, and at that time I was feeling better.
After one hour, face turned bright red like a bad sunburn. Contacted a doctor at the hospital where the high risk clinic was held.  They told me to start on a course of Benadryl every four hours.  After 24 hours, the redness subsided.
sick; Based on information previously received, the case was classified as valid as suspect was coded to Influenza vaccine  Initial information was received on 12-Oct-2020 regarding an unsolicited non-valid non-serious case from a consumer/non-health care professional (patient) via social media.  This case involves a male patient (age unspecified) who was sick (illness), after receiving INFLUENZA VACCINE  Medical history, medical treatment(s), vaccination(s), concomitant medications 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 unknown route in unknown administration site for prophylactic vaccination  On an unknown date, the patient was sick (illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE. Every time he was ordered to get the shot, he got sick. Since he stopped getting it, he did not get sick from flu. He was not going to get the shot again.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case
5 - 10 minutes of palpitations and light-headedness after the vaccination, resolving without intervention. The patient had persistently elevated blood pressure (SBP 180s) and tachycardia (HR 110s) even after symptoms resolved, which led to  notification of EMS and evaluation for transport to an ED for further monitoring. However, the patient's condition improved and EMS recommended the patient go home and follow-up with the PCP. The patient subsequently had 1 - 2 days of fever, headache, and mild nausea after the vaccination, which resolved. She did not have any other symptoms.
the pt had fever, myalgias, the following day developed swelling & redness to right calf. D-Dimer (+) resulted in US leg negative for DVT.  Swelling & redness (severe) responded to steroids orally
Bruise and soreness, burning at site. Red raised rash ranging from size of tip of eraser to dime sized, bilateral scapula area to hip area down her back only on sides. Denies itching. Rash was not warm to touch. Afebrile.
Right arm became hot, red and itchy 6 hours after injection into Other arm. Bumps appeared a few hours later that same evening. I began taking Benedryl, applying lidocaine cream for the itching and cold compresses.  The next day the arm appeared about the same and I contacted Dr. who prescribed Valacyclovir HCL 1 Gr. TID.  I took 1 around 6pm on 9/14 and the second one on 9/15 about 7am.  By noon that day the redness was subsiding and the intense itch was improved.  On 9/16 she had me see her PA who could not confirm my suggestion of Shingles.  She sent me home with some Triamcinolone Cream.  As of today, the bumps remain but are fading and the itching is much less.
10-15 days after blurred vision went away but clarity never returned.; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (10-15 days after blurred vision went away but clarity never returned.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013626A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, LEVOTHYROXINE, LOSARTAN and HYDROCHLOROTHIAZIDE for an unknown indication.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VISION BLURRED (10-15 days after blurred vision went away but clarity never returned.). At the time of the report, VISION BLURRED (10-15 days after blurred vision went away but clarity never returned.) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were reported.    This case was linked to MOD-2021-379516, MOD-2021-379645 (Patient Link).
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium
The following morning of March 31, 2021 around mid-morning I experienced nausea, generalized weakness/malaise and severe fatigue. Symptoms lasted approximately 48 hours.
influenza like illness; Sore  joints; Sore muscles; upper digestive track; felt like crap/Just feel kind of washed out; general feeling of malaise; tossed and turned all night; This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2019 10:00, the patient received Shingrix. On 18th April 2019, 5 hrs after receiving Shingrix, the patient experienced influenza like illness, joint pain, muscle soreness, gastrointestinal disorder, fatigue, general malaise and sleep restless. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the influenza like illness was not recovered/not resolved and the outcome of the joint pain, muscle soreness, gastrointestinal disorder, fatigue, general malaise and sleep restless were unknown.   It was unknown if the reporter considered the influenza like illness, joint pain, muscle soreness, gastrointestinal disorder, fatigue, general malaise and sleep restless to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After 5 hrs after vaccination with Shingrix, the patient had sore muscles and joints, upper digestive track, general feeling of malaise, just kind of feel like flu. The day before reporting at 10 am and the reporter noticed she felt like crap around 3 pm.  The patient took 2 Tilenol went to bed at 8 pm and several hours after vaccination , the patient tossed and turned all night, and just feel kind of washed out. The patient was asked how long the side effects last, just feel like the patient coming down with the flu. The reporter did not consent to follow up physician.
2 hours after the vaccine arm was stiff and very painful, got worst through out the evening. Could hardly move arm all night and into the next day. By the next day 9/20/18 was still very painful and by 7pm that evening the site was red, raised, and hot to the touch. Redness and swelling the side of a dollar bill. Today 9/21/18 still swollen and red and sore.
pain in the arm; This is a spontaneous report received from a contactable consumer. A female patient of unspecified age (reporter's friend) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and Expiration date: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain in the arm which lasted for about a month. The reporter wanted to know if the patient was "supposed to sit in pain or get an X-ray to see what was going on with the muscle or tendon in her arm". The outcome of the reported event was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Patient was admitted to an outside facility 10/06/2021.  Has multiple comorbidities including morbid obesity, obesity hypoventilation syndrome, chronic hypoxic and hypercapnic respiratory failure requiring home oxygen, COPD, right-sided heart failure with pulmonary hypertension, OSA on PAP therapy.  Tested positive for COVID-19 10/05/2021 at a local nursing home.  Had increasing dyspnea and was seen at a local nursing home due to hypoxia despite BiPAP therapy.  There was initially placed on BiPAP.  Noted to be very restless and did not tolerate well.  Was given morphine IV.  Also started on ceftriaxone and azithromycin.  Given Solu-Medrol 125 mg x1 on the 6th.
For two days after the second injection, which I received on Wednesday, February 3, I had fever and chills. I did not feel myself that Saturday or Sunday. Sunday evening, February 7, at 8:00pm, I had a Grand Mal seizure. I was transported to the emergency room by EMS, treated and released.
I had no pain or adverse reactions right after taking the vaccine, but about 5 to 7 days later I had gotten a worsened cold. The day I got my vaccine I thought I just had a hay fever, but I believe I had covid when I received the shot. I went to my doctor and tested for covid, and also had a quick test done and they both came back positive for covid. On March 15th, 2021  I was ill. I went into the hospital where I was hospitalized on March 25th. Then I was transferred from the hospital to a rehab facility on March 31st until April 23rd. I left and then had a another covid test that was negative so I had the second shot. I believe that people should get tested for covid prior to getting the shot.
Approximately 10 minutes after patient received vaccine, she became dizzy and lightheaded. Patient got vaccine at 3:07 pm. States she ate a late breakfast and did not eat any lunch.  Monitored patient for 45 minutes. No worsening symptoms. Vital signs stable. Symptoms resolved when patient left.
09-11-21: vaccine Moderma injection 09-12-01 to 09-15-21: nausea, diarrhea, and fever (99-100°F) used Imodium for nausea, diarrhea and ibuprofen and Tylenol for fever,. 09-16-21: no more fever but nausea, diarrhea used Imodium 09-17-21: nausea, diarrhea used Imodium 09-18-21 to present: nausea, diarrhea used Imodium but now I have numbness in both hands and fingers.  Difficult to open water bottle, pill bottles, taking out contact lenses.  both hands feel weak.  Difficult to type on computer.
A non-serious spontaneous report of administration of FLUMIST to pregnant female was received from a registered nurse concerning a 14-year-old female. Neither relevant medical history/obstetrical history nor concomitant medications have been reported. On 01-Nov-2010, the patient received FLUMIST for an unknown indication. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
lethargy; Tiredness; This is a spontaneous report from a non-contactable consumer. A 36-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: UNKNOWN) via an unspecified route of administration on left arm on 12Mar2021 at 12:00 (age at the time of vaccination was 37 years-old) as a single first dose for COVID-19 immunisation. The patient had not had any other vaccines within four weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent a lab test on 02Dec2020 which included nasal swab PCR test for COVID-19 and the test result was negative. On 13Mar2021 at 12:00 the patient experienced events tenderness and lethargy. Therapeutic measures for the reported events were not taken. The clinical outcome of tenderness and lethargy was recovered at the time of report. Vaccine Facility information available.   No further information is expected. Information about lot number cannot be obtained.
swelling; itching; burning; This case was reported by a consumer via interactive digital media and described the occurrence of swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced swelling, pruritus and burning sensation. On an unknown date, the outcome of the swelling, pruritus and burning sensation were unknown.   It was unknown if the reporter considered the swelling, pruritus and burning sensation to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 31-JUL-2022 Reporter's Comment: The patient self-reported this case via  interactive digital media. The patient took both the shingles shot and experienced reactions swelling, itching and burning. No shingles. Additional supportive information: The follow-up would not possible, as no contact, details were available.; Sender's Comments:  US-GSK-US2022AMR118563:Case deleted
Vaccinated with dose 1 of Pfizer COVID vaccine 1/6/21. On 1/12/2021 patient had loss of smell/taste and rhinorrhea.   Test positive for COVID.
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 26-JAN-2016 and 03-APR-2017, the patient was vaccinated with VARIVAX (lot # L035124, expiry date: 14-SEP-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
pt recvd vax; sz & convuls on 9aug94 in eve; was seen in er;had sz later on & brought back to hosp;EEG showed some poss problem according to interpreter;
side effect after receiving the Moderna Covid19 Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (side effect after receiving the Moderna Covid19 Vaccine) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (side effect after receiving the Moderna Covid19 Vaccine). At the time of the report, IMMUNISATION REACTION (side effect after receiving the Moderna Covid19 Vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Patient was not a clinical trial participant. No treatment information was provided.
The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 01-MAR-2018, the patient was vaccinated with ROTATEQ (strength were unknown, lot# N003984 and expiration date 19-NOV-2018) 1 dose form orally for prophylaxis (product storage error). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 and 23-JAN-2018 was 47 degree Celsius for max 15 hours. And on 07-DEC-2017 was 50 degree Celsius for max 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
some mild inflammation; This is a spontaneous report from a contactable consumer, the patient. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EP6955), dose 1 via an unspecified route of administration, administered in arm left on Mar2021 as dose 1, single (at the age of 53-years-old) for covid-19 immunisation. The patient was non-pregnant at the time of vaccination. Medical history included mild osteo arthritis. Concomitant medications included estradiol and progesterone. The patient experienced some mild inflammation on an unspecified date. The patient received anti-inflammatory and flexorall as treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient had not diagnosed with covid-19 prior to vaccination and had not tested for covid-19 since the vaccination. The outcome of the event was not recovered.  Follow-up attempts were completed. No further information was expected.
fevers, rigors, body aches, fatigue and mild cognitive impairment. onset about 12 hours after vaccine. improved with acetaminophen and ibuprofen