chrisvoncsefalvay/vaers-outcomes huggingface dataset:
like flu symptoms; feel woozy; whole body was in pain; heavy nose bleeding that lasted for about a minute; had a really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (heavy nose bleeding that lasted for about a minute), INFLUENZA LIKE ILLNESS (like flu symptoms), DIZZINESS (feel woozy), HEADACHE (had a really bad headache) and MYALGIA (whole body was in pain) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A and 052E21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LABETALOL for Hypertension.   On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced HEADACHE (had a really bad headache). On 30-Sep-2021, the patient experienced EPISTAXIS (heavy nose bleeding that lasted for about a minute). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (like flu symptoms), DIZZINESS (feel woozy) and MYALGIA (whole body was in pain). The patient was treated with TRAMADOL for Headache, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and CAFFEINE, PARACETAMOL (EXCEDRIN ASPIRIN FREE) for Adverse event, at an unspecified dose and frequency. On 30-Sep-2021, EPISTAXIS (heavy nose bleeding that lasted for about a minute) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (like flu symptoms), DIZZINESS (feel woozy), HEADACHE (had a really bad headache) and MYALGIA (whole body was in pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-344147 (Patient Link).
This spontaneous report was received from a consumer reporting on her son, a male patient of unknown age, as part of a market research program. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The mother of the patient reported that on an unknown date, her son experienced syncope. Son had already had the first and second dose of, then experienced syncope. The mother refused third dose administration due to risk of death as indicated in studies from other countries (MARRS 1409USA009660). He would not take it unless he decided after age 18. At the time of the report the outcome was unknown. This is one (1) of three (3) reports from the same source (MARRS 1409USA009660, 1409USA011219 and 1409USA010733). Additional information has been requested.
Pt. stated, "I starting feeling tingling on throat and numbness on right arm 15 minutes after getting vaccinated."  Vital signs taken:  B/P 109/65, HR 104, O2Sat 97%, R 18.  At 10:36am pt. reported feeling better, numbness and tingling is going away.  At 10:38am pt. went home with husband.
Dizzy, shaking (convulsion like "per grandmother"), fainting, dropped to the floor 5-7 min after shot was given. Feels dizzy, pale, sleepy after brought back to clinic. HA & ringing ears 20 min after shot - Pulse ox 98%. Feel better after 1 hr after shot - HA was treated by TYLENOL.
inadvertently received a Adacel vaccine; few days ago that expired in Dec2021; Initial information received on 21-Jan-2022 regarding an unsolicited non-valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics who had inadvertently received a adacel vaccine and few days ago that expired in dec2021 while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date the patient had inadvertently received a adacel vaccine (accidental exposure to product) and few days ago that expired in dec2021 (expired product administered) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken  was not applicable.  It was not reported if the patient received a corrective treatment for the events (inadvertently received a Adacel vaccine, few days ago that expired in Dec2021).  At time of reporting, the outcome was Unknown for the event inadvertently received a adacel vaccine and was Unknown for the event few days ago that expired in dec2021.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt. came to clinic w/ her Mom and presented documentation per CDC card of 1st dose  moderna vaccine administered 3/17/21. Pt. 16 years of age.
suspected vaccination failure; received two doses / between 2019-2020 /In 2021 /experienced an episode of Shingles; blisters had gone away but marks are still there; marks cose; This case was reported by a nurse via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (prior to the 1st dose of Shingrix in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and skin discoloration. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, shingles and skin discoloration were unknown and the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister and skin discoloration to be related to Shingrix and Shingrix.  Additional details were reported as follows: The case was reported by the patient herself. The age at vaccination was not reported. The patient received 1st and 2nd dose of Shingrix between 2019 to 2020 (unspecified). In 2021, the patient experienced an episode of Shingles. Till the time of reporting, the blisters had gone away but marks were still there. This patient received local and topical Acyclovir for the treatment of this shingles episode. This case was considered as suspected vaccination failure as details regarding, event onset time and laboratory confirmation for shingles were unknown at the time of reporting. The reporter consented to follow up.
ACHE; CHILLS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced ache, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache, and chills. This report was non-serious. This case, from the same reporter is linked to 20210420123.
Severe intestinal cramping, nausea, slight headache.no treatment, reported to dr office,  started  3 hrs after injection, cramping, 1 hr, nausea still present 7 hrs later
Face/ cheek twitching uncontrollable.. wakes me up at night. My body feels like it's shaking, similar to low blood sugar. However, it doesn't visibly shake. It's an internal feeling.  Break through period bleeding. Last period was 2009... bleeding monthly now.
Patient had an episode of syncope 6 minutes after vaccination while seated in a chair. Arousal was difficult, carotid pulse was difficult to discern. Once conscious, patient seemed like they were going to fall in and out of consciousness, so we kept speaking to her and asking her questions to keep her conscious.  Patient began grabbing right upper abdominal quadrant and complaining of pain. She requested ice because she was feeling hot and her abdomen was hurting, ice was provided. AED was connected and 911 was called, no shock was suggested by AED.  EMT arrived and took vitals and blood sugar.  They found no issues with vitals, but suggested that she go to Hospital  for further assessment.  She was taken out on a stretcher, but it is unknown to me what resulted after she left the building.
nightmare, felt like index finger was on fire Narrative:  Patient reports that the evening of his vaccine he developed a headache, slight fever, and became weak/off balance. He reports that evening he had extreme nightmares and felt like his index finger was "on fire". He reports he is feeling better but not back to baseline for his balance. He reports he is still "wobbly". He is agreeable to come to the ER for work-up/further evaluation
Been ill ever since; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine at an unknown dose. On an unknown date, less than a day after receiving Tdap Vaccine, the patient experienced unwell. On an unknown date, the outcome of the unwell was not recovered/not resolved.   It was unknown if the reporter considered the unwell to be related to Tdap Vaccine.  Additional information received were as follows: The age at vaccination was not reported. The patient received Tdap Vaccine so that the patient could be around the new grandson who was expected in February. The patient had some of the side effects but was still worth of it. The patient was ill ever since receiving Tdap Vaccine. The patient's youngest son, the baby's father also received Tdap Vaccine and also had some of the side effects.
I developed a rash about 24 hours after my booster injection. The rash started in both arm pits and started traveling across my left breast, into the right neck, on to my right and left trunk and mid lower back.  The spread to these areas progressed over a week.  The rash is EXTREMELY itchy and burns. It is disrupting my day to day activities.
Patient sais she went home and has been vomiting. Area swollen and very red according to patient.
Complained of increased pain in left arm with muscle and nerve involvement. Area ecchymotic, patient a nurse (increased upset) state "I'm giving at "wrong area" to PMD if no better.
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
She got vaccinated on Monday 7/20/09 with ADACEL by LPN. Returned Tuesday 7/22/09 with redness & swollen on the injection site. Notified doctor.& order HYDROCORTISONE cream. To apply to until patient is okay.
pt recv vax & 3 days p/vax exp joint & stomach discomfort, bronchitis, h/a, felt lethargic;pt to MD for sx & given med;
Narcolepsy type behavior. Unexpected and severe onset of sudden sleepiness, dropping off to sleep but for extended periods, up to 2 hours.
Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient has a fear of needles.  Reported always having trouble in past when giving blood.  Patient felt flushed within a minute afterward.  She also began to feel nauseaous and vomited some.  She felt some stomach pain as well.  She sat for nearly 30 minutes and felt better over time.
I have been having pain in my "legs" for almost 18 months. The pain started almost 2 weeks after my second vaccination. I have been miserable. I have seen several PCPs, Neurology, Rheumatology, and Pain Managment, a psychiatrist, 2 different Orthopedic surgeons, and had a trip to the emergency room. I woke up one morning with the pain. Absolutely no injuries or falls prior. I ended up with covid shortly after the pain had started in my leg. During the first week of having covid, I HURT even more than I did before in my legs. I was diagnosed with Avascular Necrosis. I am currently using a walker. I have to have total hip replacement on both sides. My first surgery is on June 5th. I have not worked since April 4th, 2023.
Patient reports these adverse effects in/or around injection site after vaccine administration: Bruising for 1 week Numbness of the left thumb for 1.5 weeks Tenderness and pain for 2 months
Lower left leg painful to walk on was swollen down to the ankle tight, throbbing. Blood clots, DVT. Placed on blood thinners for 6 months.
This spontaneous report was received from a pharmacist refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 22-SEP-2016, the patient was vaccinated with improperly stored at a temperature of 14.8 F for 30 minutes ZOSTAVAX lot # M023687 (expiry date: 28-JUN-2017), subcutaneously (dosage not reported). There was a previous temperature excursion for 19 hours at 18F. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
1) Arm swelling and severe pain 2) intense muscle and joint pain with cramping of fingers, toes and calves 3) severe headache with pain that felt like intermittent lightening bolts going thru my brain. This lasted from night of injection (Monday) until the following Saturday (5 days). I took pain meds and stayed in bed for 5 days. It has now been 2 1/2 weeks and I still have muscle aches tho no longer debilitating.
PATIENT BEGAN WITH AN ITCHY THROAT AT 15 MINUTES AFTER VACCINE ADMINISTRATION AND LATER DEVELOPED AN "UNUSUAL SENSATION" TO THE BACK OF THE THROAT. EPINEPHRINE  0.3MG ADMINISTERED. IV NORMAL SALINE STARTED. DIPHENHYDRAMINE 25MG IV GIVEN. PATIENT'S SYMPTOMS RESOLVED. TRANSFERRED TO ER FOR FURTHER EVALUATION. CONTACTED ER AND WAS INFOMRED PATEINT DISCHARGED WITH NO COMPLICATIONS.
This spontaneous report was received from a registered nurse refers to a 12 years old patient who on 22-AUG-2012, was inadvertently vaccinated with a 0.65 ml dose of ZOSTAVAX subcutaneously (lot number not reported). The registered nurse stated that this was not product confusion but was related to staff error. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a female consumer refers to her daughter of unknown age. The patient was vaccinated with a first and second dose of GARDASIL (Lot #, dose and route not reported) on unknown dates. The patient did not receive the third dose at the time of specified in the PI. No adverse effect reported. It was not known if the patient sought medical attention. This is one of several reports received from a same reporter. Additional information is not expected.
Pt recvd vax 2 days later exp a fine red rash on neck & chest which was treated w/Triamcinolone cream;
Stomach rash, diarrhea, abdominal pain, and hard bump at injection spot. Diarrhea lasted 6 days, rash lasted 2 days, stomach pain lasted 1-2 days, and injection site is still present.
fever w/pox's x 1wk;tx aveeno baths & DPH;
CAUGHT COVID THREE TIMES; This spontaneous report received from a consumer via social media  via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. 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 prophylactic vaccination. 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 caught covid three times. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of caught covid three times was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000217865. This case, from the same reporter is linked to 20220239490.
excessive soreness for 2 days w/h/a treated by APAP for 1 1/2 days;
Father wanted patient to receive 3rd pfizer vaccine (booster dose). Only 2 doses documented in EHR. Patient received booster in office and after administration, father realized that the mother had taken child to get a booster at another clinic a month before.
I had a fever for 3 days and was unable to work for a week due to fatigue, body ache, and brain fog. For the next 3 weeks, I had really intense fatigue and lack of energy. If I tried to go for a brisk walk,  it would strangely give me light energy. This lasted for just about 4 weeks.
My mother had the shot on January 25. On the 30th, she became confused and was having trouble swallowing. I took her to the hospital on the 31st (Sunday). She was admitted with pancreatitis and was unable to drink water. She was then admitted to the ICU. She became septic and her mental status declined. By Tuesday, she was placed on a ventilator.  She then had renal failure and died on February 18th.
Sore Throat along with wheezing  Coughing with mucus Hoarseness in voice
(R) arm bruise, pain. Bilat leg, (R) arm red, maculopapular exanthem - 0.5cm - 2.0cm. Scattered sparsely myalgia
Pt. (10 mos) received DTaP / Hep B / IPV, HiB PRP-T, Pneumococcal Conjugate - 13 Valent, and Influenza - Quadrivalent - PF *Preferred* (6 months and older) on 10/18/2022.  On 10/21/2022, he began running a high fever, had diarrhea, exhibited twitching in right arm coupled with tilt of head to right side, and extreme lethargy.
None noted I gave monovalent adult Pfizer as a booster dose instead of the bivalent adult Pfizer vaccine. There was no harm to the patient. Action: All healthcare providers received training on the bivalent booster vaccine. Monovalent and bivalent vaccines are labeled in the storage unit. The job aid and infographics are posted.
18 month old received Tdap instead of Dtap-developed diarrhea after 5 days
Swollen arm at injection site, raised knot felt under skin; warm to touch, red.
Husband received his second dose of Moderna  Covid 19 two and half moths later on 26May2021yo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Husband received his second dose of Moderna  Covid 19 two and half moths later on 26May2021yo) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, ACETYLSALICYLIC ACID (ASPRIN), PREDNISONE and METOPROLOL for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Husband received his second dose of Moderna  Covid 19 two and half moths later on 26May2021yo). On 26-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Husband received his second dose of Moderna  Covid 19 two and half moths later on 26May2021yo) had resolved.            This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no AEs reported.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no AEs reported.