chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 64-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2017, at approximately age 63, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dosage and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated at an eye institute for the treatment of stroke and blindness resulting from her use of ZOSTAVAX. At the time of the report, the outcome of cerebrovascular accident and blindness was unknown. The reporter considered that cerebrovascular accident and blindness were related to ZOSTAVAX. Upon internal review, cerebrovascular accident and blindness were considered to be medically significant. Additional information has been requested.
Thrombocytopenia 14000 on admission.  Was at the dentist day before and had cleaning No bleeding at that time.  Most recent platelet count in computer in 2017 was 144,000.  patient had BMB showing Amegaryocyte no schistocytes Was treated with steroids IVIG no improvement.  Had Nplate  4/14/2021 and  4/21/2021 no improvement..  Had also HLA match platelet transfusion for platelet < 10,000.  Today 04/22/2021 platelet count 4,000
Slightly red around left deltoid where DTaP was administered. Itchy and blotchy.
Admitted to hospital on 12/14/21 due to ankle fracture from MVA. found to be COVID positive but asymptomatic. MOderna on 08/29/2021 and 10/3/21
Headache; felling warm; This is a spontaneous report from a non-contactable other HCP. A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via intramuscular on 22Dec2020 15:30 on left deltoid at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient denied any history of previous adverse reactions to vaccines. The patient was given the Pfizer vaccination in the left deltoid muscle. During her 15 minutes waiting period after the injection, the patient began to experience headache and felling warm. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis. The patient was told to receive Tylenol and no side effects. The patient was stable to go home and follow up with PCP. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Reports he has been diagnosed with Guillain Barre syndrome. Symptoms started with 2 fingers tingling 1/11/21. Progressively increasing in severity. Now has numb fingers and toes. Initiating IV therapy 1/22/21.
On 12-06-17 received annual flu vaccination in left shoulder. Within approximately two (2) hours developed soreness, stiffness. Over the following days the symptoms continued to increase to include significant pain (dull resting - sharp moving), loss of range of motion, weakness, and twitching/tremors. These conditions negatively impacted sleep. I have had two (2) follow-up physician visits; Dr. on 12-18-17, who referred me to Orthopedics on 12-21-17. X Rays taken; diagnosed as Bursa Impingement Syndrome (BIS). Attending PA was not familiar with SIRVA. Researched online and stated BIS SIRVA was same condition. Since that time, symptoms have continued with little improvement. Next appointment scheduled for 01-05-18.
New Thrombocytopenia, discovered prior to hip surgery.  Platelet count was normal in January 2021 when hip dislocation occurred.  Also having increasing frequency of heart palpitations.
Patient notified of vaccine used drawn up greater than 12 hours. Notified by MD and no advers events. Patient will get 2nd vaccine as scheduled.
Large red, painful, swollen lump at injection site; 99.4-degree fever X 2 days, nausea, vomiting X 2, inability to eat, muscle pain in upper body.
This spontaneous report was received from a nurse 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 03-JAN-2017, the patient was vaccinated with VARIVAX lot # N019127, intramuscular route instead of subcutaneous. The vaccine was reconstituted with sterile diluent. No adverse effects were reported.
had tingling in my ring and pinky fingers that felt like it was falling asleep; dizziness; elevated heart rate/heart pounding; elevated heart rate/heart pounding; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 40-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EP 6955), (at the age of 40- years-old) via an unspecified route of administration, administered in Arm Right on 16Mar2021 13:45 as dose 1, single for COVID-19 immunisation. Medical history was none. Concomitant medications included ofloxacin (OFLOXACIN) taken for an unspecified indication, start and stop date were not reported. It was reported that she was not a pregnant at the time of vaccination.  She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. Patient had no known allergies. About 10 min after receipt of vaccine in right arm (16Mar2021 14:00), she had tingling in her ring and pinky fingers that felt like it was falling asleep. That was followed by dizziness and elevated heart rate/heart pounding. she had tinging. In her lips on the right side and her tongue. There was a funny taste in her mouth as well. She sat for a while but her heart was still pounding so requested to lay down. The tingling in her arm was not fully subsided 2 hours later and on 23Mar2021 seven days following first dose, the tingling recurred in the same area of her right arm, affecting the forearm and ring, pinky fingers. patient did not received treatment for adverse events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected
No adverse effects were reported.; the patient received a dose of MMRII which was reconstituted with expired STERILE DILUENT; This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, previously drug reactions, allergies or concomitant therapies were not provided.  On 13-SEP-2019, the patient was vaccinated with a dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) a dose, for prophylaxis (concentration, dose, frequency and route of administration were not reported; lot number reported as R031679, valid upon internal review, and expiration date reported and determined on 01-NOV-2020). It was reported that the vaccine was reconstituted with expired sterile diluent (MERCK STERILE DILUENT) (concentration, dose, frequency and route of administration were not reported; lot number reported as N011475, valid upon internal review, and expiration date reported and determined on 08-AUG-2019) (expired product administered). No adverse effects were reported.
Health department COVID clinic nurse administered 8 year old the incorrect vaccine. The patient was there to receive a bivalent booster but instead received the adult bivalent booster vaccine. The nurse was not aware of the medication error until the admin staff entered the information into the system and the family had already left. Per standing orders patient waited their 15 minute observation time and had no adverse reactions at that time. MD was contacted by nurse and went over the error and standing orders. Nurse notified the parents of the inadvertent error. Give reassurance that no adverse clinical sequellae would be likely but any worrisome post-vaccination symptom(s) should be followed up with urgent-immediate medical attention per MD contacted.
HIB vaccine was administered without proper diluent. Sterile diluent was used to reconstitute HIB, diluent lot # L008521 exp. 11/15/2017.
h/o latent TB of the lung got her 1st dose of Moderna Vaccine at  clinic and a week later developed a rash at the injection site associated with itching. Per derm, irritant vs contact dermatits which could be related to the shot. Treated with Lidex ointment and Zyrtec.  dermatologist Dr.:  Favored Diagnosis: irritant vs contact dermatitis which  could be related to the shot
Pain in left arm just below site of injection. 101 degree fever with dehydration, severe lightheadedness, and headache that lasted till morning. General feeling of weakness and exhaustion that lasted till evening the next day.
the needle was not on secure enough and the fluid from the vaccine leaked everywhere/ no AE; the needle was not on secure enough and the fluid from the vaccine leaked everywhere/ no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves (unknown age and gender) patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number: UJ288AB, Expiry date: 30-Jun-2020) via unknown route and site of administration on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to needle issue and vaccine underdose.   It was reported that she administered a Fluzone High-Dose to patient however the needle was not on secure enough and the fluid from the vaccine leaked everywhere.  At the time of report no adverse event was reported.  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 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.
Information has been received from a nurse practitioner concerning a female (age unreported), with concomitant medication, pertinent medical history and drug reactions/allergies reported as none, who was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 657737/0522U), IM on an unspecified date. The second dose of GARDASIL vaccine (yeast) (lot # 655322/1211U) was given IM on an unspecified date. Immediately after vaccination the patient experienced numbness of the arm where the injections were given following both her first and second dose of GARDASIL vaccine (yeast). The numbness stretched from where the shot was given and all the way down her arm. The patient sought unspecified medical attention. The patient was treated with acetaminophen (TYLENOL) and subsequently recovered approximately 2 days after vaccination. Additional information has been requested.
Got immun @ 645 PM; seizure activity @ 930 same PM x 10-15 minutes observed by parents; eyes rolled back, body shook, skin pale in color; took to ER by 10PM; examined & released that PM;
Ringing in the ear involving both ears; Felt very tired; Arm was swollen really bad for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen really bad for 4 days), TINNITUS (Ringing in the ear involving both ears) and FATIGUE (Felt very tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen really bad for 4 days) and FATIGUE (Felt very tired). On 11-Apr-2021, the patient experienced TINNITUS (Ringing in the ear involving both ears). On 08-Apr-2021, FATIGUE (Felt very tired) had resolved. On 10-Apr-2021, PERIPHERAL SWELLING (Arm was swollen really bad for 4 days) had resolved. At the time of the report, TINNITUS (Ringing in the ear involving both ears) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.
Swollen Lips; Fluffy Lips; Funny lips; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (Funny lips), LIP SWELLING (Swollen Lips) and LIP OEDEMA (Fluffy Lips) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030821A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ORAL DISCOMFORT (Funny lips). On 06-Mar-2021, the patient experienced LIP SWELLING (Swollen Lips) and LIP OEDEMA (Fluffy Lips). At the time of the report, ORAL DISCOMFORT (Funny lips), LIP SWELLING (Swollen Lips) and LIP OEDEMA (Fluffy Lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  treatment information was not provided.
Started with weakness in legs, and by November 12 had severe balance problems and legs could not hold him. Went to the ER they sent him home, he fell at home. Had to have EMS come and take him to the hospital. From  hospital they sent him to different hospital because he wouldn't walk. The doctor there, Dr. sent him back to first hospital because he was getting weaker. First hospital sent him back to different hospital even though he could not walk or sit up and was loosing feeling in his hands. Was sent back to first hospital where was  than dignosed with Gilliam Barre Disease by the Neurologist Dr. at hospital. Was moved to Hospital for rehabilitation where Dr. attributed this diagnoses to the Flu Shot. He is still there for rehab.
This spontaneous report as received from a registered nurse concerning a patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 11-JUL-2014, the patient was vaccinated with a first dose of GARDASIL lot # reported as: V014219, expiration date: 05-OCT-2015 for prophylaxis (dose, and route of administration were not reported). On 16-AUG-2014, the patient received the second dose of GARDASIL, expiration date: 19-JUN-2016 for prophylaxis (dose, route of administration and  lot number were not reported). The patient received the third dose of GARDASIL, lot # L018286, expiration date: 13-APR-2017 for prophylaxis (dose, and route of administration were not reported), on 13-JUL-2015. No adverse effects reported. Lot number V014219 is an invalid lot number for GARDASIL. Sender's Comments: US-009507513-1709USA004083.
Pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Pericarditis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Feb-2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). The patient was treated with CLONIDINE for Symptomatic treatment, at an unspecified dose and frequency and MORPHINE for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PERICARDITIS (Pericarditis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter.  The patient had a pace maker put in on 23-Feb-2021 and had pericarditis the same day. About two weeks before Easter, the patient had pain every time she took a breath like she was going to have a heart attack.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship is unlikely.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship is unlikely.
Child's mother called on Tuesday (02/15/2022) at 11:20 Am. After trying to return several times was able to contact her at 3:00Pm. Mother states child has a rash on both right and left thigh where vaccines was received . Ask parent when the reactions start, she stated on Saturday 02/12/2022 24 hours later. Ask parent if she took child to ER or to pediatrician or a doctor, she stated no. She stated the rash was itching and. Ask mother if child had a reaction before after receiving vaccines, she stated yes when she received 4 month old vaccines at the pediatricians office.( Note: before receiving vaccines o n Friday 02/11/2022 mother notated no reaction from vaccines before). She stated the pediatrician told her "it was ok and the rash would go away because a rash was normal". Ask the parent to bring child back to facility because we need to see the rash . Parent returned to this facility at 4:20 PM on 02/15/2022. Note rash on both thighs with multiple raised areas. No temp. 97.8 axillary and advise parent to take child to Medical Center for further evaluations and further treatment or take to pediatrician.  Mother stated she would take to medical center or to pediatrician.
Large swollen lump on injection site, extremely painful and hot to the touch.  Sore throat, congested sinuses, nausea, body aches, fatigue, brain fog and headache.
Headaches, fatigue, nausea, muscle aches, and feeling hot or cold.
Pt developed severe headaches 3 wks after receiving vaccine - underwent a multitude of tests and treatments. Headaches  finally resolved after craniosacral manipulation 6/04.
approx 3 hrs p/vax pt started high pitched crying that lasted for 3-4 hrs; mom called MD but did not go in to see the MD; MD told mom not to take a chance to take pertussis again;
COVID-19 Arm Large red swelling at site of injection on Feb 9 Headache Chills Severe Vertigo
Delayed subcutaneous hypersensitivity. Swelling and itching eight days after injection.   Original pain at injection site lasted four+ days, went away, then this happened overnight.
approx 3yrs p/vax pt exp varicella w/blisters covering the scalp, face & more moderate blistering on torso & below the wrist. pt mom est pt had greater than 100 lesions. treated w/benadryl & aveeno.
Sore arm, swollen eye (lump under the skin and visible in the rim of the eye, fatigue, malaise, headaches, chills, diarrhea. All recovered other than the sore eye.
Sore arm; Warm to touch at the injection site; Hardness at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis, Sjogren's syndrome, Anxiety and Neuropathy.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported taking concomitant medications to treat osteoporosis, Sjogren Syndrome, anxiety, and neuropathy (unspecified).  Treatment information was not provided.
This is a spontaneous report received from a contactable consumer, the patient. An 83-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via unspecified route of administration in the left arm on 16Feb2021 at 09:30 hours (at the age of 83-years- old) as a single dose for COVID-19 immunisation. Medical history included Macular degeneration (mild), glaucoma, epstein barr, vestibular neuritis, benign paroxysmal positional vertigo(BPPV), claustrophobia from unspecified date. The patient was allergic to penicillin, epinephrine, procaine (NOVOCAINE), narcotic related codeine, erythromycin and allergic to shrimp. Concomitant medication included rosuvastatin (MANUFACTURER UNKNOWN), tafluprost (ZIOPTAN), ascorbic acid; tocopheryl acetate; zinc; xantofyl; zeanthin (AREDS), D3(MANUFACTURER UNKNOWN) and sambucus nigra (ELDERBERRY) from an unspecified date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9262) via an unspecified route of administration in the left arm on 26Jan2021 at 08:30 hours (at the age of 83-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 13Mar2021, at 01:30 hours, the patient awakened at middle of the night with sudden loud tinnitus. Panic attack was experienced, had claustrophobia anyway so exacerbated the issue. The event resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received anti- anxiety prescription as treatment for the events. The patient went to physical therapy facility for balance and ear crystal treatment and it was continuing at the time of this report. The patient was under evaluation. The clinical outcome of the event panic attack and tinnitus was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient became hypotensive, tachycardic after feeling dizzy, upper back aches and lip tingling.
24 hours after vaccination pt noticed that area around vaccination site became red, swollen, hard and itchy.  This spread down her arm to her wrist and there was some pain.  It took a week for it to go away.  Pt. decided it was in line with side effects on VARS sheet so did not contact Dr. or pharmacy