chrisvoncsefalvay/vaers-outcomes huggingface dataset:
WITHIN 24 HRS PATIENT HAD OVER 100 DEGREE TEMPERATURE, LETHARGIC, IRRITABLE, SLEEPLESS, AND SWELLING AROUND INJECTION ON RIGHT ARM.  OVER THE NEXT SEVERAL DAYS, WEEKS, AND MONTHS BECAME EVEN MORE SLEEPLESS, IRRITABLE, WITHDRAWN, SYSTEMIC, AND AUTISTIC.  Medical Records received on 2/18/2005 states communication-language disorder, CNS dysfunction, diminished muscle tone, and gross and fine motor delays. 60 Day Follow up: food intolerances, leaky gut syndrome, IBS flare ups, autism, encephalopathy, diminished motor skills, unable to communicate. Pt is in speech and occupational therapy. He attends therapy twice weekly to assist in the recovery.
Menstrual cycle is regular, lasts 8-14 days long, on birth control, (Nexplanon) . Menstrual cycle began 4/22/21 was supposed to finish on 5/6/21, day of vaccine administration. 1 hr after vaccine administration  of the vaccine, menstrual became stronger, had heavier flow, and patient experienced dizziness and fatigue. 5/15/21, menstrual cycle is still strong and has been continually going for 23 days. Current CBC and estrogen count unknown.
A couple of days after the vaccine, my lymph nodes in armpits were swollen and neck lymph nodes were swollen for a couple days. It was uncomfortable nut not painful. No fever, no malaise. I did feel nauseous during this time. 2 weeks after my vaccine (around 05/22/2021) I had a weird sensation that my left arm went numb and I couldn't really control it 100%. I went to the ER because I thought I was having a stroke and because of my experience with Bells Palsy. They didn't do anything because I was in the lobby waiting for 2-3 hours and they seemed rushed and they told me that I must've been sitting in weird position because my arm went numb. They didn't do any tests.
Patient was given vaccine with no reaction until 10 minutes later at which point patient developed 2 small welts at injection site. Patient then found to be lethargic and diaphoretic and hardly responsive to name. BG 181 mg/dl. BP 160/96 mmHg, HR 92 BPM. Denied SOB, CP, trouble swallowing - airway not compromised. Patient then started to lose consciousness and moan. Oxygen sat 97-100%. Epinephrine 0.3 mgs IM and diphenhydramine 12.5mg PO given. Patient seemed to respond better but unsteady on his feet. Patient then fully alert and answering questions. He was transferred to local ED.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Dec2022 as dose 5 (booster), single (Lot number: GJ6738) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history.  No known allergies . There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
FLUSHING Narrative:  Patient felt flushed after injection. This cleared quickly and no additional medications were required.
Redness, swelling, pain in Lt arm around injection site. Chills x 3 days following injection. Blistering in mouth, nose, & on lips. Pain in posterior neck with looking up-red patch present on skin, posterior neck.
There was an allergic reaction to the shot on her right thigh causing 4.5" x 2.5" local reaction with redness without any pain or warmth to the touch. No treatment was given, but her father was advised to notify us of any additional reactions and go to the ER if she develops any symptoms of anaphalaxis.
19 days post vax the pt experienced a fever of 102. She took ibuprofen and the fever was gone four hours later. She later experienced joint pain that started in her left wrist and right index finger. She also experience muscle pain in the right side of her neck. She reported that the muscle and joint pain moved around. She also experienced right great toe pain. The pt then developed erythema migrans on her back and received 21 days of treatment of Doxycycline at half dose. She also experienced generalized back muscle pain, bilateral knee joint pain and left arm to shoulder muscle pain. She also had difficulty sleeping due to the symptoms. The most recent information reports the rash and fever have resolved but the joint pain remains.
Initial unsolicited report received from nurse on 15-Aug-2018. This case involves a female patient (age unknown) who stabbed her hand while taking green cap of vaccine PENTACEL. (Batch number C5264AA, expiration date 29-Oct-2018), on an unknown date. The patients medical history and concomitant medications were not reported. It was reported that on unknown date, 8 individual doses of PENTACEL have broken, nurse went to take little green cap off it and it shattered in her hand, the bottom shattered and stabbed her hand. Description of complaint: Supervisor calling to report that in total 8 individual doses of PENTACEL have broken. This particular time, today, the nurse went to take the little green cap off it and it shattered in her hand. The bottom shattered and stabbed her hand. Other vials, sometimes it separates at the neck. Sometimes when the nurses pull the vials out the box the bottom falls out. Some have holes in the base or around the shoulder, looks like it had been shot with little holes in it, leaving no liquid inside. Lab data and corrective treatment were not reported. Outcome of the event was unknown. List of documents held by sender- none.
Covid19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Covid19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2020, the patient experienced COVID-19 (Covid19). On 14-Jan-2021, COVID-19 (Covid19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
wherever the swelling is, it moved; arm swelling a little; arm has been really red and warm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (arm swelling a little), ERYTHEMA (arm has been really red and warm) and SWELLING (wherever the swelling is, it moved) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN for Hypertension, BISACODYL (DULAX [BISACODYL]), PRAVASTATIN, ANASTROZOLE, LEVOTHYROXINE and DULAGLUTIDE (TRULICITY) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm swelling a little) and ERYTHEMA (arm has been really red and warm). On an unknown date, the patient experienced SWELLING (wherever the swelling is, it moved). At the time of the report, PERIPHERAL SWELLING (arm swelling a little), ERYTHEMA (arm has been really red and warm) and SWELLING (wherever the swelling is, it moved) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Customer is having tingling sensation up and down his left arm, and he stated that his shoulder is sore. Asked him is pain severe he said that it is easing up a little. 4-9-09.
Pulsatile tinnitus in right ear.  This is a symptom I have never had in my life.  It has persisted since onset.
About 15 minutes post injection, difficulty swallowing, throat swelling, lightheadness, weak. Took 50 mg of Benadryl, contacted the nurse for assistance. Was given nebulizer treatment of albuterol and Ipratropium. NP stated my throat was swollen and difficulty passing air in right lower lung base. Vitals stable. Sent to ED for evaluation. 5 days of prednisone, every 8 hour dose of 25 mg Benadryl, and emergency inhaler if needed.
Per husband, patient had right-sided stiffness. Arm and hand rigid. She threw-up once, then napped for about 2 hours. She was back to normal after her nap. Patient encouraged to go to  doctor. I am not sure if she went.
Moderna COVID-19 Vaccine  Day 1 after injection, malaise, fatigue, dizziness. Day 2 after injection, major nausea with significant bouts of vomiting lasting approximately 12 hours. when that resolved, severe and recurrent diahrea for another 8 hours. I will decline the 2nd dose.
pt recv vax 21SEP98 & started having hives 25SEP98 more hives on 26SEP98 & progressively worse through 28SEP98;had office visit on 28SEP98 had hives on palms;hives ongoing 29SEP98;never difficulty breathing;
Patient is a is a 62 y.o. male  status post bilateral lung transplant for interstitial lung disease (ILD) on 7/11/19 who presented to clinic for routine f/u. He states he has been feeling "puny" for a few weeks. He states he sleeps all the time, he is soa, he has decreased appetite, nausea and vomiting. His spiro was found to be decreased and creatinine was also elevated in clinic. The decision was made to admit him to the hospital for further work up.   COVID Pneumonia (POA) COVID PCR positive on 1/25/22 Completed Dexamethasone, Remdesivir and Baricitinib.  Return to Prednisone 10mg daily following discharge.  Cefepime and Ceftaroline as empiric treatment for secondary bacterial pneumonia; given during admission. Will discontinue upon discharge.   Discharge Disposition/Condition Disposition: Home Condition: Stable (s/sx potential problems absent or manageable)
Arm hurt very badly immediately during and after vaccine in similar sensation to ulnar nerve being struck in arm, bled only a little but caused swelling and then a large bruise developed over the evening of 4/4/2021 and is still dark today (4/7/2021). Concerned my bone was hit with a too long vaccine needle. Had chills/fever evening of 4/4/2021 into morning of 4/6/2021?had to take off work. Have had neurological symptoms ongoing with ?brain fogginess? since 4/5/2021. On 4/6/2021, began to see flashes/spots of light in vision of left eye, which worsened through today. Took off afternoon from work and went to an eye clinic to have eye dilated and looked at, but the spots in vision continue through reporting time (4/7/2021, 5pm CT).
Small 1 to 2 inch rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Small 1 to 2 inch rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Urticaria and Penicillin allergy (Reaction- Rash).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Small 1 to 2 inch rash). At the time of the report, RASH (Small 1 to 2 inch rash) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided No treatment medication information was provided   This case was linked to MOD-2021-046895 (Patient Link).
*Soreness in arm with red round mark the size of a quarter lasting 5 days, with swelling lasting a week at minimum (had hysterectomy 6 days following vaccination so my attention was no longer focused on vaccination site swelling - not sure when swelling went down)  *Very noticeable sunken in area about 2 inches in diameter where shot was administered, first noticed 2-3 weeks ago. Feels like atrophy or either fat or muscle. It can be described as a dent with a pit when you put pressure on the area. The skin looks normal, it does not look like a smallpox shot scar. Contacted my primary care physician, but she is out of the office for two weeks. Made an appointment with her on June 3rd to determine whether it would be advisable for me to have the second shot of the series, which is overdue.  I cannot find any information about this reaction online so I am concerned.
SIRS; Administered flu vaccine intravenously; This is a spontaneous case, initially received from pharmacist via Agency (reference number: SEQ19-02270) on 04-Sep-2019, concerning a 33-year-old female patient.  The patient's medical history included chest pain, symptomatic anaemia and viral gastroenteritis.  The patient's concomitant medications included ferrous sulphate, amitriptyline, Duoneb (ipratropium bromide, albuterol sulfate), Zofran (ondansetron), Percocet (oxycodone, acetaminophen), oxycodone, Miralax (polyethylene glycol 3350) and senna; all for unknown indication.  On 11-Jan-2019, while was in hospital due to chest pain related to anemia, the patient was administered intravenously Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, batch number: YG40008, expiration date and anatomical location not reported] (explicitly coded as Inappropriate route of vaccination') for influenza prophylaxis. On the same day, the patient was discharged home.  On 12-Jan-2019, one day after vaccination, the patient developed nausea and vomiting with elevated white blood cell count. The patient was readmitted to hospital and diagnosed with Systemic inflammatory response syndrome (SIRS).  On 15-Jan-2019, the event of SIRS was resolved.  It was unknown if the event of SIRS was caused by IV administration of influenza vaccine or from viral gastroenteritis.  The reporter assessed the case as serious.  Company Comment: The patient experienced systemic inflammatory response syndrome after incorrect route of the suspect product Afluria Quadrivalent administration (reported as flu vaccine intravenously administered). Chronology is plausible. Medical history of anaemia and viral gastroenteritis may have contributed to development of the event systemic inflammatory response syndrome. Causality was also confounded by therapy with multiple concomitant medications. Considering all the above mentioned, causal relationship between the suspect product and the event systemic inflammatory response syndrome is assessed as related and as not related for incorrect route of product administration.; Reporter's Comments: The patient experienced systemic inflammatory response syndrome after incorrect route of the suspect product Afluria Quadrivalent administration (reported as flu vaccine intravenously administered). Chronology is plausible. Medical history of anaemia and viral gastroenteritis may have contributed to development of the event systemic inflammatory response syndrome. Causality was also confounded by therapy with multiple concomitant medications. Considering all the above mentioned, causal relationship between the suspect product and the event systemic inflammatory response syndrome is assessed as related and as not related for incorrect route of product administration.
Pain and swollen lymph nodes, several weeks later numbness and tingling in left side of body.
Patient had brief LOC for about 15 seconds within 1-2 minutes after receiving vaccine. Obtain vitals - normal. On way home, pt. vomited x1, per mom. Later in day doing well, back to normal.
This spontaneous case reported by a consumer, describes the occurrence of illness (started getting really sick/feeling sick), influenza (flu-like), pain in extremity (left foot still hurts), peripheral swelling (left leg swelled up) and decreased appetite (appetite is off) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 051F21A) for COVID-19 vaccination. The occurrence of additional events detailed below. The patient's past medical history included blood clot. Concurrent medical conditions included type 2 diabetes mellitus. On Nov 20, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 20, 2021, patient had pain in extremity (left foot still hurts), peripheral swelling (left leg swelled up) and pain in extremity (left arm was sore for 3 days). On Nov 28, 2021, patient experienced illness (started getting really sick/feeling sick), influenza (flu-like), decreased appetite (appetite is off), dizziness (dizzy) and vomiting (throwing up for 3 days). Patient treated with acetylsalicylic acid (baby aspirin) for swelling of legs, at an unspecified dose and frequency. On Nov 22, 2021, pain in extremity (left arm was sore for 3 days) resolved. On Dec 1, 2021, vomiting (throwing up for 3 days) resolved. At the time of the report, illness (started getting really sick/feeling sick), pain in extremity (left foot still hurts) and dizziness (dizzy): not resolved. Influenza (flu-like) and decreased appetite (appetite is off) outcome unknown. Peripheral swelling (left leg swelled up): resolving. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medications not provided.
Appro 5 min after getting GARDASIL pt passed out. Was placed in a laying post and monitored for 30 min.
Agitation; Heart pounding; Heartbeats increased; Sternal pain; Vaccination adverse reaction; Premature atrial contraction; Bone pain; Atrial flutter; Throat discomfort; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of AGITATION (Agitation), PALPITATIONS (Heart pounding), HEART RATE INCREASED (Heartbeats increased), CHEST PAIN (Sternal pain) and VACCINATION COMPLICATION (Vaccination adverse reaction) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LATANOPROST and TIMOLOL for an unknown indication.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGITATION (Agitation), PALPITATIONS (Heart pounding), HEART RATE INCREASED (Heartbeats increased), CHEST PAIN (Sternal pain), VACCINATION COMPLICATION (Vaccination adverse reaction), SUPRAVENTRICULAR EXTRASYSTOLES (Premature atrial contraction), BONE PAIN (Bone pain), ATRIAL FLUTTER (Atrial flutter), OROPHARYNGEAL DISCOMFORT (Throat discomfort) and ARTHRALGIA (Joint pain). At the time of the report, AGITATION (Agitation), PALPITATIONS (Heart pounding), HEART RATE INCREASED (Heartbeats increased), CHEST PAIN (Sternal pain), VACCINATION COMPLICATION (Vaccination adverse reaction), SUPRAVENTRICULAR EXTRASYSTOLES (Premature atrial contraction), BONE PAIN (Bone pain), ATRIAL FLUTTER (Atrial flutter), OROPHARYNGEAL DISCOMFORT (Throat discomfort) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Non-Significant Follow up
stuffy sinuses; a measles-like rash; fever; This spontaneous report was received from a pharmacist and refers to a 36-year-old non-pregnant female patient. The patient's concurrent condition included drug reactions/ allergies to bupropion hydrochloride (WELBUTRIN) and citalopram. No information regarding the patient's pertinent medical history and concomitant therapies was provided.  On 16-AUG-2019, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) injection, lot # S014429 and expiration date 09-MAY-2021, subcutaneously (exact dose was not provided) for prophylaxis (reported as "needed booster for employment in the medical field"). On unspecified date in 2019, the patient experienced fever, stuffy sinuses and a measles-like rash. The outcome of sinus congestion, pyrexia and rash morbilliform was reported as recovered on 19-SEP-2019, when the patient came to the pharmacy. No causality assessment was provided by the reporter.
OVERDOSE; PRODUCT ADMINISTRATION ERROR; NOT OBVIOUS LABELING ON VIAL; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. 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. 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 overdose, product administration error, and not obvious labeling on vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the overdose, product administration error and not obvious labeling on vial was not reported. This report was non-serious. This report was associated with product quality complaint 90000182226. The suspected product quality complaint has been confirmed to be pqv management approval - confirmed no pqc was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed.
Initial and follow-up information has been received from a nurse concerning several patients who were vaccinated with Pneumovax. No lot number provided. It was reported that several patients experienced "fever", "injection site pain" and "other random complaints". At the time of the report it was unknown if the patients recovered. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. In follow-up it was reported by the licensed practical nurse. (L.P.N.) that approximately 10 patients, mostly males all 50 plus (+) complained of not being able to move their arms, soreness, and an almost "paralysis" in the injected arm. The L.P.N. could not confirm if the patients were given the same lot of product. The remaining vials were discarded and a new batch was requested. Upon medical review it was determined that no being able to move their arms, and almost "paralysis" were considered other important medical events. Additional information has been requested.
8 days after the 1st dose of Moderna vaccine, left upper arm at injection site developed a rash and was swollen, red, warm and itchy but not painful.  The rash grew in size and ultimately was a full hand width with wide spread fingers width on upper arm.  At day 7 the rash started easing and after day 8 was completely gone.    The 2nd vaccine on 3/31/2021 (Moderna Vaccine 008B21-2A) was administered in right arm.  After consultation with nurse regarding previous reaction to first dose, the right arm was decided for injection just as a precaution.  3 days after the injection, a small rash occurred with same symptoms as first dose, but only lasted 3 days then completely disappeared.  As of today, 4/27/2021, there have been no further reactions or symptoms of any kind.