chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red flashes across her face, down the neck / redness on hips, forearms, and thighs; developed a sore throat,; developed an allergy.; started itching for two nights,; developed hives./ Hives on hips, forearms, and thighs; could not move her body.; not feeling well that day; extreme fatigue, but was not sleepy; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (could not move her body.), MALAISE (not feeling well that day), PRURITUS (started itching for two nights,), URTICARIA (developed hives./ Hives on hips, forearms, and thighs) and ERYTHEMA (red flashes across her face, down the neck / redness on hips, forearms, and thighs) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A, 046A21A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced MOBILITY DECREASED (could not move her body.), MALAISE (not feeling well that day) and FATIGUE (extreme fatigue, but was not sleepy). On 15-Nov-2021, the patient experienced PRURITUS (started itching for two nights,), URTICARIA (developed hives./ Hives on hips, forearms, and thighs) and HYPERSENSITIVITY (developed an allergy.). On 17-Nov-2021, the patient experienced ERYTHEMA (red flashes across her face, down the neck / redness on hips, forearms, and thighs) and OROPHARYNGEAL PAIN (developed a sore throat,). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for Adverse event, at a dose of 6 day course; FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (could not move her body.), MALAISE (not feeling well that day), OROPHARYNGEAL PAIN (developed a sore throat,), FATIGUE (extreme fatigue, but was not sleepy) and HYPERSENSITIVITY (developed an allergy.) outcome was unknown, PRURITUS (started itching for two nights,) and URTICARIA (developed hives./ Hives on hips, forearms, and thighs) had not resolved and ERYTHEMA (red flashes across her face, down the neck / redness on hips, forearms, and thighs) had resolved. No concomitant drug details were reported. Patient states she went to urgent care on 17-Nov-2021. If she stops taking Allegra or Benadryl the itching comes back. She cannot go without 2 hours when it wears off.
pt recv vax & devel flu-like sx characterized by h/a,chills,& fever of 100.4;
This spontaneous report as received from a nurse practitioner refers to a 4 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 02-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had a temperature excursion. No information on patient's concomitant medication was provided. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Originally I just had flu-like symptoms (chills, fatigue, headache) for four days and slight pain in injection site. Since then the pain in my arm around the injection site has only worsened. I have to use pain relief on my shoulder and arm to dull the pain which never goes away. I believe some damage has been done to the muscle with this injection.
Pt got 3rd Hep B injection 1.0 mL IM (R) deltoid on 9/4/14 AM. She states she woke up at 4 AM 9/5/14 uncomfortable with a rash. Pt called the clinic and was advised to come into the clinic. Pt arrived at 1600. At that time face, nose and cheeks had hives. (R) arm from injection site to hand had multiple hives. She had hives on chest, neck, back, both arms and legs. No hives on palms.
stomach was very upset; stomach painful; I am weak; nausea; loss of appetite; Sick with nausea; felt a little bad; This non-serious case was reported by a consumer and described the occurrence of upset stomach in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 31st July 2023 and felt cruddy but no stomach issues refer linked case US2023AMR157970).   On 01-NOV-2023, the patient received the 2nd dose of Shingrix. On 01-NOV-2023, less than a day after receiving Shingrix, the patient experienced feeling bad (Verbatim: felt a little bad). On 02-NOV-2023, the patient experienced upset stomach (Verbatim: stomach was very upset), stomach pain (Verbatim: stomach painful), weakness (Verbatim: I am weak), nausea (Verbatim: nausea), appetite lost (Verbatim: loss of appetite) and sickness (Verbatim: Sick with nausea). The outcome of the upset stomach, stomach pain, sickness and feeling bad were not reported and the outcome of the weakness, nausea and appetite lost were not resolved.   It was unknown if the reporter considered the upset stomach, stomach pain, weakness, nausea, appetite lost, sickness and feeling bad to be related to Shingrix.     It was unknown if the company considered the upset stomach, stomach pain, weakness, nausea, appetite lost, sickness and feeling bad to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR157970   Additional Information: GSK Receipt Date: 05-Nov-2023 and 07-Nov-2023 The patient was self-reported this case. The patient reported that he received 2nd dose of Shingrix vaccine on last Wednesday and on the same day in afternoon and in night he felt a little bad and then from the next day and every day he experienced stomach was very upset and painful usually in the evening after he eat.  Patient cannot eat very much at all so he was weak. The patient stated that on 2nd November 2023, 1 day after received Shingrix vaccine experienced felt sick with nausea and loss of appetite which was unresolved. Patient was planning a long flight on Tuesday and he was not sure he can go if he still feel this way.  The reporter wanted to know if is this normal, and how long will this last. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR157970:Same Patient Same reporter Different Dose
Nausea, vomiting, fever, headache, redness and soreness at injection site.
After receiving her booster dose of moderna covid 19 vaccine, (0.25ml) pt reported a very swollen arm to the pharmacy on 11/20.  She stated that it was red, itchy and very swollen.  This started the day after vaccination- ice packs and her prescription antihistamine have helped but it has remained inflamed.  I counseled her that this was not unheardof, to continue what she has been doing and contact her dr if it remains bothersome on monday or worsens in the meantime.
Soreness at right side prior to flu shot. Hard to concentrate when doing computer work. Applied ice to shoulder for 30 minutes. No Epi administered. Had Patient move head side to side successfully. No redness, itching, and swallowness at site. Participant states symptoms have subsided by 3:00 PM. Feeling fine.
Employee woke up at 5am feeling hot at sweaty with stomach ache with dull pain that felt like pressure and gas. She noticed site of vaccination was warm and red with induration of 2x1 inches.  At 10am she started to have a headache, and began itching at injection site. Donor took acetaminophen for headache and was instructed to take benadryl when she gets home.
Pt denied redness until day 2, large red raised area below injection site, rt deltoid BENADRYL advised.
Vaccine administered at 1338. At 1355 patient reported no symptoms. At 1406 patient reported itching in the throat and ears. NP evaluated patient and administered 2 benadryl by mouth at 1411. At 1424 patient left clinic reports feeling better without any symptoms.
SIDE EFFECTS OR ILLS DUE TO VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergic to some ingredients. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced side effects or ills due to vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from side effects or ills due to vaccine. This report was non-serious.
This spontaneous report as received from a registered nurse refers to a 7 month old male patient. On 07-FEB-2014 the patient was vaccinated with LIQUID PEDVAXHIB dose 2. The nurse reported that the patient received LIQUID PEDVAXHIB that was improperly stored and was determined in to be unsupported by in-house stability. Nurse also reported that the patient received the first dose of LIQUID PEDVAXHIB on 06-DEC-2013. It was reported that the patient needs to be revaccinated for his second dose. No adverse symptoms were reported. No PQC. Additional information has been requested.
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer Sponsored Program. A contactable male consumer of unspecified age reported that he received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, after the first dose, the patient tested positive and lost his taste and smell. He also mentioned that his brother and mother were tested positive. Events outcome was unknown. Information on the lot/batch number has been requested.
Woke up suddenly at 3:30am freezing and shivering.  Every bone, joint, muscle hurt. Headache at neck, top of head and forehead. Fatigue.   No fever,    After first vaccineshot, lymph node at collar bone on right side arose about the size of a large pea.it took 5 weeks for it to disappear.
At about 1410 hours a female began complaining about her breathing & having difficulty. She had recently just received the vaccine minutes before the adverse conditions began. She was given an EpiPen & was recovering after
Pt states vaccine hurt immediately and still hurts 2 days later. Pt states she is unable to lift her arm over her head.
Pt had immunization delay.  Tdap ordered.  DTaP administered.  Guardian was called to inform her of error & to monitor for increased pain, tenderness.  She stated since immunization a few hrs prior child "loopy" & confused-he asked her several times when he had to go back and couldn't remember answer.  She stated he was self now.  No seizure no fever.  Instructed to ED if any recurrence or any level of concern.
Had the shot and Had shingles/Suspected Vaccination Failure; Shingles in left eye; Shingles, mild case in forehead and hair; Very painful; Headache was terrible; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shot and Had shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles in left eye) (serious criteria GSK medically significant), shingles (Verbatim: Shingles, mild case in forehead and hair), pain (Verbatim: Very painful) and headache (Verbatim: Headache was terrible). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, shingles, pain and headache were not reported.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, pain and headache to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, shingles, pain and headache to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 18-MAR-2023 The case  was received from the patient via  interactive digital media. The patient had shingles last year and it was very painful and had a mild case in the left eye, forehead and in his/her hair. The patient stated that headache was terrible and headache 2 weeks before broke out.  The patient had the Shingle shot and booster. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Fever, chills, excess sweating, dizziness, pain in injection site, pain in underarm, swelling in underarm, tightness in chest, tightness in underarm
Pain in feet; Extreme tiredness continued/ fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in feet) and FATIGUE (Extreme tiredness continued/ fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in feet) and FATIGUE (Extreme tiredness continued/ fatigue). At the time of the report, PAIN IN EXTREMITY (Pain in feet) and FATIGUE (Extreme tiredness continued/ fatigue) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-065561 (Patient Link).
This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns a 78-year-old, elderly male patient. On 16-Oct-2018, the vaccine underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2018) which underwent temperature excursion. The patient had not experienced any adverse event after the vaccine administration. The reporter assessed this case as non-serious. This case 201805012 was cross-linked to the case: 201805002 reported by the same reporter. Follow-up report received on 13-Nov-2018: The reporter refused to provide the patient's initials. The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The narrative and case comment were amended accordingly.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L004014, expiration date 04-MAR-2017 (doses and routes of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
got Covid with symptoms; got Covid with symptoms; back pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP,). The reporter is patient's husband.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Oct2021 (Lot number: EW0191) at the age of 79 years as dose 3 (booster), single, administration date 06Mar2021 (Lot number: EN6198) as dose 2, single and administration date 13Feb2021 (Lot number: EN6201) as dose 1, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII) (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing). There was no Family Medical History Relevant to AE(s). Concomitant medication(s) included: LEVOTHYROXINE [LEVOTHYROXINE SODIUM] taken for thyroid disorder (ongoing). The patient did not receive prior vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s). There was no AE(s) following prior vaccinations. No sample of the product was available to be returned, if requested.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Feb2022, outcome "unknown" and all described as "got Covid with symptoms"; BACK PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "back pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: got Covid-19, will call the doctor to ask if they should be retested. The patient took Paxlovid as treatment for COVID-19 from 14Feb2022 night. The reporter asked if patient can take Ibuprofen, because patient had back pain from the covid and coughing a lot. The reporter clarified that patient's back pain started with the cough from the Covid, and then patient started taking the Paxlovid after the cough started. The reporter stated that he and his wife(patient) got both Covid shots and their boosters and they both still got Covid, but only his wife(patient) had symptoms. The reporter would call the doctor after this phone call to ask if they should be retested.
Began experiencing heart palpitations the day after the injection.  symptoms appear to be non-life threatening.
RAISED RED MARK IN THE AREA OF SHOT; AREA OF SHOT HURT; HEADACHE; TIREDNESS; PAIN IN THE NECK; BITTER TASTE IN THE MOUTH; NASAL DRIPPING; DRIPPING BACK OF THROAT; SWELLING OF TONGUE; SORENESS OF BODY; DIFFICULTY IN BREATHING; PAIN IN RIGHT ARM; CHILLS; SHOULDER HURT; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip surgery, and knee replacement, and concurrent conditions included atrial fibrillation, hypertension, diabetes, gastrooesophageal reflux disease, rheumatoid arthritis, multiple myleloma, egg allergy, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient did not had any drug abuse or illicit drug use. The patient experienced drug allergy when treated with diphenhydramine hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and batch number: 041A21A expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 10:00 for prophylactic vaccination. Concomitant medications included apixaban for atrial fibrillation, metformin for diabetic, torasemide for diuretic, omeprazole for gastrooesophageal reflux disease, pantoprazole for gastrooesophageal reflux disease, amlodipine for hypertension, eplerenone for hypertension, sodium perborate monohydrate for hypokalemia, paracetamol for rheumatoid arthritis, atorvastatin, and ubidecarenone.  On 08-APR-2021, the subject experienced pain in the neck. On 08-APR-2021, the subject experienced bitter taste in the mouth. On 08-APR-2021, the subject experienced nasal dripping. On 08-APR-2021, the subject experienced dripping back of throat. On 08-APR-2021, the subject experienced swelling of tongue. On 08-APR-2021, the subject experienced soreness of body. On 08-APR-2021, the subject experienced difficulty in breathing. On 08-APR-2021, the subject experienced pain in right arm. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced shoulder hurt. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tiredness. On 12-APR-2021, the subject experienced raised red mark in the area of shot. On 12-APR-2021, the subject experienced area of shot hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bitter taste in the mouth, nasal dripping, dripping back of throat, swelling of tongue, and difficulty in breathing on 08-APR-2021, and chills on 12-APR-2021, was recovering from raised red mark in the area of shot, and area of shot hurt, and had not recovered from headache, pain in the neck, pain in right arm, tiredness, shoulder hurt, and soreness of body. This report was non-serious.
Possibly given compromised vaccine ( vaccine reconstituted and administered with sterile water instead of manufacturer's diluent). No reported adverse health events by patient in subsequent visit to the Immunizations clinic. Revaccination determined by local medical team with advice from the following medical professional. *Item 5 was filled due to form requirement but it is unknown if patient has experienced an adverse health event. This VAERS form is being filled out for documentation and education purposes. 22JUL2019
An attorney reported that a male patient received injections of Hib-Titer (Hemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate), Acel-Imune (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed), and Tetramune (diphtheria and tetanus toxoids and pertussis adsorbed and hemophilus b conjugate vaccine (diphtheria crm 197 protein conjugate) as part of his childhood immunizations. It is alleged that, as a result of Thimerosal and the mercury and/or other heavy metals contained in the vaccine, he had the following symptoms: severe learning disabilities, impairments in social relatedness, language and communication difficulties, abnormal movements, sensory dysfuntions, depression, anxiety, hearing loss, severe bowel dysfunction, and other severe health disorders. The reporter also stated that them patient also was exposed to heavy metals from the emissions of a chemical plant. These events were considered medically important. No further information was available as of the date this was reported
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 04-JAN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # L037790, expiration date: 30-DEC-2016) (dose, route of administration and injection site were not provided). No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
left index finger numbness, left hand numbness, left leg numbness, bilateral feet numbness, let arm soreness Narrative: