chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 female patient received BNT162b2 (BNT162B2), on 07Sep2021 as dose 2, single (Lot number: EW0186) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Covid-19 Vaccine:, Dose 1: Date: Unknown, LOT: EW0186), for Covid-19 Immunization, reaction(s): "Brain fog". The following information was reported: FALL (non-serious) with onset 12Sep2021, outcome "unknown", described as "fell over"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog"; BALANCE DISORDER (non-serious), outcome "unknown", described as "completely lost her balance/ lost her entire balance system"; VESTIBULAR DISORDER (non-serious), outcome "unknown", described as "having vestibular issues"; COGNITIVE DISORDER (non-serious), outcome "unknown", described as "cognitive problems"; MALAISE (non-serious), outcome "unknown", described as "didn't feel good". Clinical course: Additional Context: Has a question about the Covid-19 vaccine. Took the vaccine a year ago and after the second dose, she sat up one day and fell over. She completely lost her balance. Still recovering. It was suggested to her that she could've gotten a bad batch or something. Has anything been reported or is just the way she is responding to the vaccine. She lost her entire balance system. She cant drive, ride a bike, had to re learn a lot of things, having vestibular issues, cant do her career. Had to relearn how to ride her bike. Her biggest concern is just the LOT. Wants to get better. She was really terrified that she may have had something different than everyone else. Has anything like that been reported? Both her vaccines were the same LOT numbers. Had severe brain fogs after the vaccines. With the first vaccine, the brain fog went away after the first night. But it came back after the second vaccine and she is now having cognitive problems. After the second vaccine, she didn't feel good for a couple of days. On the fifth day, she stood up and completely fell over. Ever since then she's been recovering. She fell over on 12Sep2021. Received the second dose on 07Sep2021. Had no underlying conditions or anything or known problems. Was in a healthy state. That is all she really has to say or add about it.   Description of Product Complaint: Description of complaint: Due to AE patient experienced after receiving vaccine, it was suggested to her that she could've gotten a bad batch or something. Her biggest concern is just the LOT. She is really terrified that she may have had something different than everyone else.
have had covid 5x; still not having my second dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (have had covid 5x) and PRODUCT DOSE OMISSION ISSUE (still not having my second dose) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Dec-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 COVID-19 (have had covid 5x) and PRODUCT DOSE OMISSION ISSUE (still not having my second dose). At the time of the report, COVID-19 (have had covid 5x) and PRODUCT DOSE OMISSION ISSUE (still not having my second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Patient too came down with symptoms but tested negative twice and Positive.     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.   No concomitant medication was provided.  Patient was due for second shot in January of 2022 and her husband had tested positive the day before patient shot.   It was reported that patient had covid 5 times in their household which here patient now still not had second dose.   Patient tried last week to find the second dose of the Moderna series.  Treatment medication was not provided by the reporter.
Injection on 10-11-17. 10-12-17 - Aches, fever. 10-14-17 - Fatigue, weakness, vomited once, loss of appetite. Has not missed any work but states may go to MD.
High blood pressure, low oxygen, high/low heart rate (not stable)  ambulance to the emergency room, received IV fluids, H1 & H2 inhibitors, prednisone
Patient's spouse called the pharmacy to report that the patient began feeling achy all over with an intense headache beginning the evening following the flu shot. The patient did not report running a fever or having any nausea/vomiting.
A spontaneous report was received from a consumer concerning a 75-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event, Pain in extremity. The patient's medical history included high cholesterol and hypertension. Concomitant medications reported were rosuvastatin To treat high cholesterol, carvedilol To treat high blood pressure. On 1 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 1 Mar 2021, the patient experienced the event, a little minimal soreness in the left arm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of event, a little minimal soreness in the left arm, was unknown.
Patient got worked up and anxious during shot. After shot given patient had hives/welps on stomach. Patient looked at by EMS and improved without intervention.
Tongue feels "weird" and throat is tight. Placed on oxygen and provided 25 mg Benadryl. BP 147/71 HR 113
Felt like all her teeth were falling out; She's clinching her teeth; Teeth were hurting very badly; Jaws were hurting; Feels like clinched jaw; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH LOSS (Felt like all her teeth were falling out), BRUXISM (She's clinching her teeth), TOOTHACHE (Teeth were hurting very badly), PAIN IN JAW (Jaws were hurting) and JAW DISORDER (Feels like clinched jaw) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A2IA) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced TOOTH LOSS (Felt like all her teeth were falling out), BRUXISM (She's clinching her teeth), TOOTHACHE (Teeth were hurting very badly), PAIN IN JAW (Jaws were hurting) and JAW DISORDER (Feels like clinched jaw). At the time of the report, TOOTH LOSS (Felt like all her teeth were falling out), BRUXISM (She's clinching her teeth), TOOTHACHE (Teeth were hurting very badly), PAIN IN JAW (Jaws were hurting) and JAW DISORDER (Feels like clinched jaw) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment details were not provided.   This case was linked to MOD-2021-429723 (Patient Link).
Dose 1 - Sore arm Dose 2 - Sore arm, headache, general malaise (Took about 24 hrs to recover - took 3 doses of 600mg ibuprofen 6 hrs apart (total 1800mg  over the course of 18hrs
a patient was administered the first dose of MMRII at 12 months old and was administered a second dose of MMRII at 15 months old; No adverse effects were reported; This spontaneous report was received a licensed practical nurse referring to a 15 month old patient of an unknown gender. No information was provided regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies.   On an unknown date, at 12 months old, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (dose, route of administration and anatomical injection site were not reported). At 15 months old, the patient received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (dose, route of administration and anatomical injection site were not reported) (inappropriate schedule of product administration). Both vaccines were reconstituted using an sterile diluent (dose, route of administration, anatomical injection site, lot number and expiration date were not reported). No adverse effects were reported.
presumptive cellulitis; Initial information received on 01-Aug-2022 regarding an unsolicited valid  serious case received from a physician.  This case is linked to 01226124 and 01226199.  This case involves a 20 months old of an unknown gender who had presumptive cellulitis after receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE , with an unknown formulation and strength, (lot : C5816AA ; expiry date: not reported) for immunization.  On an unknown date the patient had presumptive cellulitis (cellulitis) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.  It was reported that 3 kids received the suspect vaccine and 2 out of the 3 were started on antibiotics for presumptive cellulitis. All three kids were doing better.   Action taken : not applicable.  At time of reporting, the outcome was Recovering for the event presumptive cellulitis.; Sender's Comments: Sanofi company comment date 09-Aug-2022: This case involves a 20 months old of an unknown gender who had presumptive cellulitis after receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. Other medication, current illness, preexisting conditions and allergies were not reported. Also,  the time to onset of event and latency is not provided to assess the role of the vaccine. Further information such as circumstances leading to and patient's health status directly preceding the reported event and the results of investigations to research an alternative etiology such as infectious check-up is missing to fully assess the case
Pt vaccinated with Pneumovax 23 developed pain, swelling & redness at the injection site & felt "hot & achy all over". Treated w/Cefadroxil.
Information has been received from a registered nurse concerning a female patient who in approximately April 2002, was vaccinated with a dose of hepatitis A virus vaccine inactivated. The reporter indicated that about a year ago the patient had a reaction within 24 hours following the vaccination. She developed a non-vesicular rash on the face, cheek, ear, and eye (on both sides of face). The treatment included hydroxyzine embonate, prednisone, and hydrocortisone cream. It was not known how long it took for the reaction to resolve. Unspecified medical attention was sought. It was indicated that the patient recovered. A product quality complaint was not involved. Follow up was received from the registered nurse which indicated that no further medical information was available. No further information is expected.
Woke up with Atrial Fibrillation that would not stop,  Went to local hospital in  They treated me with medications but they had no effect. I was transported to  Medical Center in  where they continued the medications. When they did not work, I was sedated and my heart shocked back into rhythm.
Patient received first dose of Pfizer COVID vaccine 0.3 mL at our facility at 5:06PM on 1/13/22. The LOT number for the vaccine is FJ1620. The vaccine label states it expires 02/2022. However, the vaccine is only usable for 30 days after it has been in our vaccine fridge. The vaccine has been in our fridge for 40 days, meaning it expired on 01/03/2022.
A non-serious spontaneous report of administration of FLUMIST to an individual over 49 years of age was received from a registered nurse involving a 77-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 11-Sep-2009, the patient received FLUMIST. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. On 20-Oct-2009, it was confirmed that the patient did not experience any adverse events.
Information has been received from a RN concerning a male (age not provided) who in early Oct 2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650331/0749P). Subsequently, the pt developed injection site reaction. The pt was reported as recovered. There was no product quality complaint involved. The registered nurse also provided information regarding another pt's experiences with pneumococcal 23v polysaccharide vaccine (WAES0511USA02165, 0511USA03746). Additional information has been requested.
Patient had blistery welts or poxlike sores appear all over hands, including palms. The pox did not ooze. Doctor diagnosed it erroneously as hand foot and mouth despite the fact that there were no other rashes nor fever. Patient contracted actual hand foot and mouth on 9/5/2016, developing a fever, sores in mouth, on bottoms of feet, and on the palms of his hands.
admit 2/25, vaccine 1/18, 2/12. COVID PNA, acute RF. Treated w/zinc, steroids, abx. DCd home.
Severe headache starting the evening of the vaccine. The following morning, noticed severe swelling in mouth. Headache persists.
Admitted with hypoxic respiratory failure, RLL/RML pneumonia and COVID. Treatment includes: Oxygen, antibiotics.
The Patient received 2 vaccines on 11/03/20. Based on the information given to the Pharmacy by the patients Spouse the patient was feeling unwell that evening and there was evidence of swelling in the Arm. The patient was taken to the Drs office  and was prescribed antibiotics  for cellulitis. The patient is also being treated for Atrial fibrillation per information given by the spouse.
fever, rash at site, swelling at site, diarrhea, generalized joint pain
The morning after I received my first dose, I started feeling muscle weakness, my eyes could not focus, I knew I was having a myasthenia crisis. My whole body started shutting down, even my breathing. I immediately went to the hospital, I was admitted into the ICU with onset symptoms at home until I got an IVIg infusion it was less than four hours. I had three of the IVIg infusions. The nurses did a general work up of blood work, an EKG, and CT. I had a catheter. I was in the hospital ICU for 5 days, then was sent to the rehabilitation center starting January 31st, and went home on the 8th of February. With continued rehab for many weeks afterwards. On the 15th of March I started doing rehab at home.
PT REPORTS THAT THE DAY AFTER RECEIVING TDAP VACCINE, THE LEFT SIDE OF HER NECK BECAME TIGHT AND SORE.  SHE NOTICED A "LUMP" ON HER LEFT COLLAR BONE WHICH IS EXAMINED BY THE RN AND FOUND TO BE AN ENLARGED CERVICAL LYMPH NODE.  NODE IS APPX 3MM AND TENDER TO PALPATION.  PT HAS BEEN INSTRUCTED TO WATCH NODE AND TO SEE MD SHOULD ENLARGEMENT PERSIST.  NO REDNESS OR SWELLING IS NOTED AT THE INJECTION SITE (LEFT DELTOID).
Soreness at the injection site; Redness at the injection site-size of a quarter; Bumps/hardness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Bumps/hardness around the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site-size of a quarter) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to lisinopril, metformin HCL, tessalenpark.). Concomitant products included CARBIDOPA, LEVODOPA (CARBIDOPA LEVODOPA), GLIMEPIRIDE, EMPAGLIFLOZIN (JARDIANCE), ESCITALOPRAM, CICLOSPORIN (RESTASIS), LOSARTAN, INSULIN DEGLUDEC (TRESIBA), HYDROXYCHLOROQUINE, BIOTIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), MACROGOL 3350 (MIRALAX), CYAMOPSIS TETRAGONOLOBA GUM (BENEFIBER FIBER SUPPLEMENT), FUROSEMIDE, CALCIUM, METOPROLOL TARTRATE, ALBUTEROL SULFATE, FLUTICASONE PROPIONATE and NYSTATIN for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Bumps/hardness around the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site-size of a quarter). On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE INDURATION (Bumps/hardness around the injection site) had resolved and VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site-size of a quarter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Following immun, pt devel copious runny nose, rash worsening over 3-4 days, conjunctivitis, & cough; On exam 11AUG had confluent morbilliform rash, conjunctivitis, & suspicious buccal white spots, & OM; poss Influenza; F/U pt improved;
5 inch swelling and redness in the area of injection, hard, hot to the touch, itchy.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The  concomitant medications on use were not provided. No laboratory data was provided. No treatment information was provided.   This case was linked to MOD-2021-149880 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow-up document was received on 19-MAY-2021. The outcome of event sore arm was updated to recovered. It contains significant information.; Sender's Comments:  MOD-2021-149880:Same patient, 2nd dose
positive COVID-19 test; positive COVID-19 test; loss of taste; loss of taste and smell; This is a spontaneous report from a non-contactable consumer, the patient. This report was received via a sales representative. A 30-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 12Apr2021 as dose 2, single and for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient stated that, recently on an unspecified date in 2021, she had received a positive COVID-19 test and loss of taste and smell. These loss of taste and smell have begun to return to normal after three days. She also reported that the event took place after use of product and she did not wish to be contacted for follow-up. The patient underwent lab test which included COVID-19 test: received a positive COVID-19 test on an unspecified date in 2021. The outcome for the event positive COVID-19 test was unknown and loss of taste and smell was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt's daughter states that after each COVID19 vaccine her mother is "confused and paranoid usually around the 5th day after injection". This confusion lasted for 2 weeks after first vaccine and then patient returned to baseline. After second vaccine confusion and paranoia resumed and was still present at time of call on 3/2/2021.
Pt  administered Pfizer vaccine on 1/8/22 at approx. 3:08 pm. About 5 minutes after receiving the vaccine she fainted in the waiting chair and had some seizure-like activity. She awakened approximately 10 to 15 seconds later. Code White was called by myself, a fresh water was grabbed and pt offered a cold compress. Parents were asked if 911 should be called by myself as pt was woozy after waking. Parents were there at the time comforting patient. Pt was ok and left after waiting approximately 30 more minutes. I will also report to Vaers as soon as getting done with this
This spontaneous report as received from a pharmacist refers to a male patient of unknown age, the patient had no pertinent medical history or drug reactions or allergies. On 25-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001004, expiry date 24-APR-2014, route was subcutaneous). No concomitant medications were reported. On an unknown date, the patient experienced a swollen, hot red, rash around the injection site. There was no treatment rendered for the events. There was no lab tests performed. The outcome of the reported events were not recovered. The patient sought medical attention (called the reporting pharmacist). Additional information has been requested.
Information has been received from a physician concerning a 15 year old female patient with no known drug allergies/drug reactions who on 05-FEB-2009 was vaccinated with the first dose of GARDASIL (Lot # 1423X). Concomitant therapy included hormonal contraceptives (unspecified). It was reported that on 31-MAR-2009 the patient experienced "vaginal ulcer". The patient sought unspecified medical attention. "HSV testing and Mono testing" were performed (results not provided). It was reported that the patient had not recovered at the time of the report. Additional information has been requested.