chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Painful menstruation with large blood clots; Painful menstruation with large blood clots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Nov2021 12:00 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cystic fibrosis" (unspecified if ongoing). No Covid prior vaccination. Concomitant medication(s) included: ZENPEP. No other vaccine in four weeks. The following information was reported: THROMBOSIS (medically significant), DYSMENORRHOEA (non-serious) all with onset 04Dec2021 12:00, outcome "recovering" and all described as "Painful menstruation with large blood clots". The event "painful menstruation with large blood clots" and "painful menstruation with large blood clots" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of thrombosis, dysmenorrhoea. Clinical course: No covid tested post vaccination. AE resulted in Doctor or other healthcare professional office/clinic visit No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is a 21-year-old male without significant past medical history who presented to the hospital in the early morning of 9/24/2021 with complaint of chest pain that had started about 30 minutes prior.  It did not wake him from sleep.  Patient can point to the location of his chest pain which is around the intersection of the left midclavicular line and rib 8.  Leaning forward improves the pain.  Lying down worsens the pain.  Pain is rated at 8/10 at its worst but when laying down with head of bed elevated, his pain is 0/10.  Patient reports his breath ?catching? if he takes a deep breath (which also worsens the pain) but otherwise denies shortness of breath, cough, orthopnea, peripheral edema.  He denies any symptoms suggestive of a viral infection, to include myalgias, arthralgia, URI symptoms.  He has had no rashes or engaged in recent travel.  He has no family history of autoimmune or heart conditions.  He received the first dose of his COVID-19 vaccine (Pfizer) 15 days prior.
I have been contacted by several of my clinics that the needles included with the RABAVERT are not safety needles and pose a hazard to staff. Packaging includes 2 non-safety needles - one for reconstitution and one for administration. Potential issue - there have not been reports of needlestick injuries (yet).
This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a female patient who received SHINGRIX for prophylaxis. On 19th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 2nd August 2018, 14 days after receiving SHINGRIX, the patient experienced itchy rash and blister. On an unknown date, the outcome of the itchy rash and blister were not recovered/not resolved. The reporter considered the itchy rash and blister to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was administered the 1st dose of SHINGRIX. Within two weeks, she developed a rash on her face which had not dissipated before getting her 2nd dose on 31st October 2018. The rash will blister up, pop, then subside just to flare up again and they are itchy. The rash was restricted to her face. Her condition had not improved since her 2nd dose. She had seen her healthcare provider who was sending her to a skin doctor. Emergency room visit Required. The patient reported her pharmacy had been in contact with GSK about her case but could only provide the name and location of the pharmacy. The patient's health care professional.
Chest Tightness, Body Aches, Diarrhea, Increased Blood Pressure, Vomiting, Weakness, Headache
Information has been received from a nurse concerning a female patient (age unknown) who, on an unspecified date, was vaccinated with a dose of HPV. Subsequently, on an unspecified date, the patient passed out after receiving the vaccine. The nurse reported that the patient had not eaten. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Pregnant when vaccinated (both doses), due date of 10/31/21. Induced at 37 weeks due to hypertension, baby born at 6lb 3oz. On 10/7/21 I started noticing loss of facial function. 10/8/21 my OB/gyn sent me to the ER due to facial paralysis, they diagnosed me with Bells Palsy on the right side. I was given a one week course of Prednisone and valtrex. 9 weeks post diagnosis I am seeing limited movement in my mouth but remain mostly paralyzed.
only the Arexvy adjuvant was administered; only the Arexvy adjuvant was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 24-OCT-2023, the patient received Arexvy. On 24-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: only the Arexvy adjuvant was administered) and inappropriate dose of vaccine administered (Verbatim: only the Arexvy adjuvant was administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 25-Oct-2023 No other patient details or product details were available as pharmacist was calling from home and was not at pharmacy. The reporter consented to follow-up. The patient only received Arexvy adjuvant one day before the reporting, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
(L) leg and arm weakness x 4H, difficulty ambulating x 4H, facial flush x 4H, (L) facial edema x 4H.
30 minutes after receiving injection, acute onset severe stomach cramping and nausea. No fever, vomiting, diarrhea. Symptoms lasted 15-20 mins, then resolved completely.
Mom states he c/o side discomfort upon awakening that AM. Received Hep B #3 about 9 AM. By lunchtime c/o side pain, achiness, problems with breathing concerns. Given Advil, felt better. Went to soccer practice. By evening, temp 102.7, shaking, c/o aches and pains and problems breathing. Seen in ER.
Numbness in legs, arms and face. Was difficult to stand and walk. Insomnia and night sweats. Anxiety and depression since the flu vaccine. I take medication for and they have been working well for years until I received my flu shot.
She tested positive for Covid-19 since the first dose; She tested positive for Covid-19 since the first dose; This is spontaneous report received from Pfizer Sponsored Programt. A contactable female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested positive for Covid-19 since the first dose and tested negative today (09Apr2021). The outcome of the events was unknown.   Information on the lot/batch number has been requested.
fever; chills; body aches; Vomited; This is a spontaneous report from a contactable consumer (Parent). A 23-year-old female patient not pregnant received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 08Jan2021 08:00 AM as a single dose for COVID-19 immunization, lot number: EL1283. Medical history was reported as none. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 03:30 PM via an unspecified route of administration in the Left arm lot number: EK5730. It was reported that on 08Jan2021 at 04:00 PM, after second vaccine dose that was administered at 8:00 am, patient vomited at 4:00 pm. On 09Jan2021 at 3:30 am woke up with fever, chills and body aches. No treatment received for the events. Patient was not tested for Covid post vaccination. Patient recovered from all the reported events, at the time of the report.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 18th  of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 11 years old, male patient with no pertinent medical history reported. On 29-AUG-2012 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 31-DEC-2012 the patient received another dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Developed a rash on me ankle a week after the vaccine and it spread over 90 percent of my body over 6 months.
This is a spontaneous report from a contactable nurse and physician communicated to a Pfizer sales representative. A 16-year-old male patient received first dose of TRUMENBA, (Lot number and Expiry date not provided), via an unspecified route of administration on an unspecified date at single dose indicated for age, MENACTRA, via an unspecified route of administration on an unspecified date at unknown dosage for immunization. Medical history included history of fainting. No concomitant medication information was provided. The patient fainted after he left the clinic after receiving the TRUMENBA vaccine. This occurred in the alley way before stepping onto the street. The patient had a history of fainting spells. This was the first dose of TRUMENBA that he had received. He also received MENACTRA and TB screening the same day. The mother walked the patient back in clinic and he was kept for an additional 15 minutes and his blood pressure normalized. The reporter did not have blood pressure readings. The outcome of the event was unknown.
Day 1 (3/24)  dizziness, nausea, body aches, headache, Temp 99.9    Began taking tylenol routinely every 4-6 hrs Day 2 (3/25)  worsening symptoms, body aches, headache (worse with standing),  Temp 100,6 Day 3 (3/26)  Temp 102.0; violent shaking, chills, body aches, fatigue, unable to stand, weak Left arm at injection site - very sore
Headache, Myalgia, Fever, chills, hot flashes, dizzy Narrative:
Still get sharp pain at the vaccination sites as of 05Feb2023 in both arms at different times, not continuous!; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 04May2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Anatomical location: Right arm), for COVID-19 immunization, reaction(s): "Still get sharp pain at the vaccination sites as of 05Feb2023 in both arms at different times, not continuous!", "Vertigo". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Still get sharp pain at the vaccination sites as of 05Feb2023 in both arms at different times, not continuous!".  Additional information: Patient stated "I looked into the VAERS list and seen there is many that are also getting pain at the injection site. I also reported mine to the VAERS list. With all the many vaccinations I have had over the many years this is the only one that has done this! What is it?"  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300079655 Same reporter/patient/drug/AE, different dose of vaccine;
Within 30 minutes I had brain fog, headache, and kept feeling really bad and had a tension head ache. I had high blood pressure and they diagnosed me with high blood pressure and migraines. I keep having alot of migraines, I have tingling arms and legs for weeks and I've developed anxiety. On May 6 I went to neurologist and was diagnosed with migraines and began having chest pain. As of 7/23/2021 I have to have a heart monitor.
Presented to the ED due to shortness of breath.  Was seen 1 day earlier on 01/29/2022 for similar symptoms and was found to be COVID positive.  Had normal saturations on room air was discharged home per his request.  Return to the ED via EMS due to worsening shortness of breath, fatigue.  Patient does admit to non-compliance with diet by eating a pizza, which resulted in increased LE edema and sob.  Per EMS patient's oxygen saturations was in the 80s on their arrival.  Patient placed on supplemental oxygen with improvement in oxygen saturation.  On arrival to the ED, ABG revealed 7.37/34.4/64.5/20 with normal anion gap. - Chest x-ray with bilateral opacities that appear as pulmonary edema however cannot rule out multifocal pneumonia.  Patient received a complete course of remdesivir, discharged with 2 more days to finish decadron.   Discharged 2/7/22.  Patient previously vaccinated with Moderna 3/11/21 & 4/7/21  LOT #'s unavailable
Narrative:  This patient has been vaccinated with COVID 19 vaccine. It is unclear which vaccines, since there is no documentation in our facility. The patient presented to the ED on 11 June 2022 with cough, fever, and nausea. The patient was admitted to the hospital on 11 June with COVID 19 pneumonia and anemia. The patient was treated with antibiotics and with oxygen. The patient was discharged in stable condition on 17 June 2022. Reported per EUA.
No additional AE/PQC; HCP called to report an inadvertent administration of GARDASIL 9 to an infant instead of PREVNAR 20.  Administered today 11/1/2023 to a 1 yr old male. No adverse effects were reported. Request case reference 02501053. Consent to contact is yes.  No a; To a 1 yr old male; This spontaneous report has been received from a physician, regarding a 12-month-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 01-NOV-2023, the patient was erroneously vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliters as prophylaxis (lot number: W026152, which was determined to be valid as syringe formulation, with an expiration date reported as 24-JAN-2025, but confirmed to be on 29-JAN-205), instead of pneumococcal vaccine CONJ 20V (CRM197) (PREVNAR 20) (wrong vaccine administered, Product administered to patient of inappropriate age).   No additional adverse event was reported.
Two days post first vax, he experienced flu-like symptoms, muscle pain and joint pain. No treatment given. The most recent information, received on 05/01/2000 reports that flu-like symptoms resolved and the joint and muscle pain are ongoing. The follow up describes the occurrence of joint pain in a 55 year old male who received the first injection of LYMErix for prophylaxis. Follow up has been received from the responsible physician; however, he was not able to verify the adverse events reported. The pt has no known drug allergies. Concurrent clinical condtiions includes elevated cholesterol and stomach problems NOS. Concurrent medications include Pravachol and Prilosec. On 4/6/00, the pt received his first dose of LYMErix. According to the pt, two days later he experienced flu-like symptoms, muscle pain and joint pain. No treatment was given. Per the pt on 5/1/00, the flu-like symptoms resolved and the joint and muscle pain were ongoing. According to the physician's office, there was "no notation that the pt complained of anything at all, including any vaccine related problems" on 5/8/00. The pt received the second injection of LYMErix on 5/8/00 and has subsequently not reported any events to the physician. The event of 'joint pain' does not meet serious criteria, but is being submitted expeditiously for informational purposes.
Was fine until one week after the vaccine.  Vommited once seven days after the vaccine.  On the eighth day he started to limp on the right leg which is where the vaccine was injected.  Has continued to limp for eight days so far.  Bruise appeared over vaccination injection site on the 13th day after the vaccination was given.  Started to grind teeth on the 14th day after vaccination.  Today is the 15th day after vaccination and he's still limping.
I got symptoms of severe body aches and high fever. I got a positive COVID-19 test from my doctor. I took Motrin, Tylenol, and Nightquil and Dayquil. My symptoms lasted for 9 days.
Morning after the vaccine, I woke up with Itchy eyes, runny nose and sneezing.   Tried over the counter products (Eye drops:  Systane, Allergy Pills:  Zyrtec and Xyzal) for two days (3/24/21/& 3/25/21) with no relief.  Had a teleconference 3/26/21  with Physicians Assistant. Medicine prescribed:  Montelukast - 10mg and Azelastine - eye drops)  After 5 days on the medication (3/31/21) - called the Doctor to report that Montelukast was not effectively keeping me from having a runny nose and sneezing.  Prescribed addition RX of Mometasone Furate Nasal Spray - 50mg. As of 4/2/21, all symptoms have subsided enough for me to resume all activities without discomfort.
Received immunizations at 9:30 am.  10:00am: ibuprofen provided; 16:00: fever began; 19:30: fever 102-vomit x1; 1:30: redose for fever-ibuprofen; 2:30: fever 104 or greater 08/13/03: symptoms improving
Information has been received from a health professional, concerning a 26 year old female patient with allergies to latex, fruit and nuts, dysmenorrhoea, menorrhagia, depression, and history of tonsillectomy and ear operation, who on 25-MAY-2007 was vaccinated IM in the right upper arm with the first dose, 0.5ml, of GARDASIL (Lot #657736/0389U). Concomitant therapy included YASMIN. On 28-MAY-2007, three days later the injection site was hard, red and itchy, and further described as "looked like a spider bite."On 01-JUN-2007, the patient reported the event, and on 04-JUN-2007, she was seen by the physician. At that time, the physician noted there was "diffuse mild erythema" with no bruising. Bloodwork testing was ordered, with all results normal. At the time of this report, the patient was recovering from the events. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/6/2007. Initial and follow up information has been received from a health professional (HCP), concerning a 26 year old female patient with allergies to latex, fruit and nuts, dysmenorrhoea, menorrhagia, depression, and a history of tonsillectomy and ear operation, who on 25-MAY-2007, at 10:00am, was vaccinated IM in the right upper arm with the first dose, 0.5ml, of GARDASIL (Lot #657736/0389U). Concomitant therapy included YASMIN. On 28-MAY-2007, three days later the injection site was hard, red and itchy, and further described as "looked like a spider bite". On 01-JUN-2007, the patient reported the event, and on 04-JUN-2007, she was seen by the physician. At that time, the physician noted there was "diffuse mild erythema" with no bruising. Bloodwork testing was ordered, with all results normal. At the time of this report, the patient had recovered from the events. No further information is expected.
PATIENT HAD A VASOVAGAL REACTION AND FAINTED AFTER RECEIVING VACCINE. WAS UNRESPONSIVE WHILE SITTING IN CHAIR FOR ABOUT 5 SECONDS THEN RECOVERED. STATED SHE HAD BLURRY VISION AND COULDN'T FEEL HER FINGERS HOWEVER AFTER ROUGHLY 30 SECONDS SHE REGAINED HER VISION AND WAS ABLE TO MOVE HER FINGERS AND TOES. EMS WAS CALLED ONCE PATIENT HAD FAINTED AND ASSESSED HER ONCE THEY ARRIVED AFTER SHE HAD RECOVERED. NORMAL BP AND HR WAS FOUND ALONG WITH NORMAL BLOOD GLUCOSE LEVEL.
Flu shot given 11/16/06 joint pain and swelling. Both ankles sore and swollen for 3-4 days.