chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from Nurse, referring to 5 patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications wee not reported. In 2017, between 18-JAN-2017 and 07-FEB-2017, the patients were vaccinated with an improperly stored dose of GARDASIL 9 with lot # L037554 and expiration date on 25-DEC-2017(anatomical route of vaccination was not provided) for prophylaxis. The Nurse stated that, GARDASIL 9, was exposed to a temperature between 0 °C and 2 °C, for a time frame of 208 hours. Data logger was not involved. Furthermore, it was reported that GARDASIL 9, was never expose to a temperature excursion before and that no product quality issue was involved. Additionally, no adverse events were suffered. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA004171: US-009507513-1702USA007841: US-009507513-1702USA007842:
Within 24 hrs of injection, developed swollen upper lip, multiple canker sores on lower lip, low-grade fever (didn't take temp, but chills), and generalized achiness & fatigue. BENADRYL and ibuprofen used x 3 days.
Patient passed out within a minute of vaccination. Mother and I moved patient to a laying down position where she immediately woke up and knew where she was and what just happened. Declined any other symptoms. Mom said she passes out often after vaccinations. Patient was conscious carrying on a conversation like normal immediately after coming to. Over the next 30 minutes I tried to get patient to a sitting position to take her blood pressure but every time we tried she needed to lay back down because she felt like she was going to pass out. After trying this twice and being unsuccessful I had EMS called to check on patient to make sure nothing more serious going on. EMS came and took a couple blood pressures and pulses which were normal. Patient was starting to feel better. Walked out with EMS and planned on going home.
Chills; Migraine; Diarrhea; very sick; Headache; metallic taste in my mouth; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (Patient).  A patient of unspecified age and gender received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW019), via an unspecified route of administration on 26Jun2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 26Jun2021, Patient took the Pfizer vaccine at withheld and felt right away that there's a metallic taste in mouth and then had nausea, vomited once and then on 27Jun2021 patient had the chills, got migraine, patient was vomiting and there's diarrhea, and asked what can be taken for headache. Patient asked whether to take Advil. patient cannot support it anymore. Patient was very sick and cannot answer. Consumer was unwilling to complete the report therefore further probing could not be done. Hence limited information available over the call. Outcome of events was unknown.  Follow up attempts needed. Further information is expected.
This case was reported by a healthcare professional and described the occurrence of malaise in a 48-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) for prophylaxis. The subject had received influenza vaccine in previous years with no subsequent adverse events and also had no adverse events following receipt of other prior vaccinations. The subject received no concurrent vaccinations or medications on 2 October 2007. On 2 October 2007 the subject received unspecified dose of Flulaval ( .5 ml, unknown, left arm). On "the evening of" 4 October 2007. 2 days after vaccination with Flulaval, the subject experienced malaise, fatigue, myalgia and body feeling warm. The subject was seen by her personal physician who wrote an order that  she was sick on 03 October 2007 and 04 October 2007 and could return to work on 05 October 2007. At the time of reporting the events were resolved. Follow-up information received on 24 October 2007 indicated that the events actually began on the same day of Flulaval administration. The time to onset was not specified. The events completely resolved by 04 October 2007. In the reporter's opinion, the events were possibly related to treatment with Flulaval. The subject saw her primary care physician and was given a prescription, but it was felt that the symptoms may have been related to the vaccine.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. the patient's pertinent medical history and drug reactions or allergies were not reported. On 26-AUG-2016, the patient was inadvertently vaccinated with a dose of M-M-R II (lot number L043702 and expiration date 03-NOV-2017, dose and route of administration were not reported) and a dose of PROQUAD (lot number M012985 and expiration date 12-SEP-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
started being light headed at noon, then just didn't feel well. like achy, by 5:00 i was having bad headache and feeling so achy in all my muscles and joints. worsened thru night with hot and cold body aches. Did not sleep for the pounding in my head and tremendous ache in body. All day the next day worsened. it wasn't till 18 hrs later i felt better but was still lightheaded.
I had what felt like electric shocks from my knees to my ankles every 30 seconds to 1 minute from 11:30 to 4am in addition to the chills and shivering
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: Patient came into pharmacy with 3 family members to receive their booster vaccine- previously had received two pfizer vaccines- walked around store before walking out to car- per family member (daughter?) patient began shaking/convulsing, unable to speak clearly, and "passed out" unresponsively. Emergency called/ems arrived prior to notification of pharmacist/pharmacy.. patient taken to hospital/emergency department
Sore arm at first. Then, began feeling achy in arms, shoulders, neck, head, and back. By about 10:30, achiness spread to entire body and bad enough to take Tylenol.  By 1:00 a.m., aches were severe throughout my entire body.  I am a healthy, active person, but that night I was absolutely miserable. Felt like I had been "hit by a train."  As achy as I've ever felt throughout entire body. Called in sick to work at 6:00 a.m.  Took ibuprofen, which helped a little.  No other symptoms except severe aches from head to toe.  By late afternoon, symptoms began to subside.  Very mild by about 10:00 p.m.  Next morning I felt perfectly normal. This was my first ever flu shot.
After approximately 5 min into wait period post injection developed numbness tingling in lips and tongue and roof of mouth. Side effect is still continuing as of today.
I had a lump come up on my left arm where I received my vaccine that was very hot and sore. The next day it seemed to head down my arm and become itchy. I watched it for 2 weeks it just continued to move. I got a cortisone injection that helped somewhat. A couple weeks after my cortisone shot I woke up in hives, with swollen lips and an itchy throat. I was not having trouble swallowing but I was clearly having a reaction to something. I was admitted to the hospital and given an IV cocktail that helped. Since then I have not received the other vaccine because the doctors and I agree it may not be safe for me to do so.
Significant stimulant effect starting about two hours after the injection and lasting about 24 hours --  preventing any sleep throughout the night.  Fever up to 100.4, chills, and fatigue, starting about 24 hours after injection and lasting for about 12 hours.  Lingering fatigue lasting for three days after the injection.
This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L033697, expiration date: 28-FEB-2017) (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 15.9 degrees Fahrenheit for 565 minutes. This is one of two reports from the same reporter. Additional information has been requested.
Having severe reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Having severe reaction) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Having severe reaction). At the time of the report, VACCINATION COMPLICATION (Having severe reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment information was reported by the reporter.
many pains; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (many pains) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (many pains). At the time of the report, PAIN (many pains) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.  It was reported that, patient was false positives for cancer with the vaccine.
After being administered COVID and FLU vaccine patient experienced extreme dizziness.  Upon attempting to stand up from immunization chair patient fell and hit her head on the door to pharmacy immunization room.  After sitting for 10 minutes patient refused pharmacy offer to call 911 and said she felt better and sat in pharmacy waiting room awaiting husband to pick her up.  After 15 minutes sitting in pharmacy waiting room patient indicated dizziness had mostly subsided.  1 hour after being administered vaccines patient left pharmacy and reported no adverse side effects.
Severe headache not responding to well to either Tylenol or ibuprofen, severe uncontrollable shaking chills, oral temperature up to 102 F.  Severe body aches, especially lower back, severe fatigue
day 1, 2= pain and tenerness in arm around injection site, headache and tiredness, coughing day 2 day 3=sore throat, ear ache, exhaustion, headache, dizziness, brain fog day 4= sore throat, headache, exhaustion day 5= coughing, exhaustion, diarrhea
Patient stated that she "didn't feel right" several minutes after she got her shot. She said that she "felt sick and was almost going to pass out". She  sat and waited at the pharmacy for awhile as instructed by the immunizer. Eventually she left after she was feeling better, but later in the day she developed a dry cough and was nauseous and had trouble breathing.  She visited a walk-in clinic the next day because her symptoms did not improve. She was diagnosed with bronchitis. She stated that she was given a steroid shot that improved her symptoms immensely. She said that she is feeling much better today and was encouraged to report the adverse event by the doctor.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: patient reported being "needle-phobic" and anxiety prior to injection but was willing to go forward with vaccine. Within 10 minutes, patient experienced tunnel vision, perfuse sweating, dizziness, nausea, and ultimately vomiting. patient reports having nausea after past vaccines but this was the first to result in true vomiting. Patient experinced all symptoms listed for atleast 35 minutes while at the pharmacy. patient able to leave with help of partner home to more quite setting to lay down
Started with a rash, on same arm as injection was given. Then he started having pain in that arm. We took him to local urgent care and he was suspicious for shingles, and was started on valacyclovir 1gm tid for 7 days
Red, swollen injection arm that?s also hot to the touch. Noticed it the day after I received The injection. So far it?s lasted 2 days.
Vomiting (lasted 1 day) & diarrhea (lasted 3 days)
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding medical history, drug reactions and concurrent conditions were unknown. On 02-APR-2016, the patient inadvertently was vaccinated with 2 vials of PNEUMOVAX23 (dose, frequency and indication were unknown) lot # L02936 and expiration date on 26-MAR-2017. Concomitant therapies were unknown. Product quality was not involved. Additional information has been requested.
swelling of the mouth; Swelling of eyelids; light headiness; tingling; This spontaneous report as received from a pharmacist refers to a 56 year old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. The patient had no known allergies.  On 10-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), by intramuscular route (strength, dose, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. On the same date, the patient went to urgent care due to swelling of the mouth and eyelids; the patient also experienced light headiness and tingling (mouth swelling, paraesthesia, dizziness and swelling of eyelid). At the reporting time, the patient had not recovered from the adverse events. The causality assessment was not provided.
Ran a  low grade fever, 99.4 usually run at 97.6; arm extremely sore a very large red spot around shot area.  As day progressed all my limbs started becoming weak and was unable to push myself out of bed, spine hurt to sit on, husband had to help me walk, get on and off the toilet. Absolutely no strength did do anything either lie in bed all day and sleep off and on.  No appetite but forced myself to eat a half sandwich .  This started at 8AM on Sat 10/19/2019 and lasted until around 11PM that night where I was able to stand and walk alone to bathroom but still needed help getting off toilet.  Fever went to99.1.. Sunday 10/20/2019 felt a little better able to move and use my arms.  Was very tired and laid down for an hr or so.  Did not react to the first shot in this series.. Today my 10/21/2019 my arm is  still red and very sore .
Information has been received from a physician concerning a 12-month-old patient who was vaccinated with a dose of VARIVAX (Oka/Merck) and eight days later was vaccinated with a dose of MMR II. It was reported that the child has been experiencing seizures. It was unknown if the child had any seizures prior to the vaccines. It was also reported that the child had developmental problems prior to the vaccination. Medical attention was sought via a phone call. The outcome was not reported. No product quality complaint was involved. Upon internal review seizures was considered to be other important medical event. Additional information has been requested.
Initial report received from a health care professional on 06 October 2011. This case is a cluster of 2 unidentified patients who experienced similar adverse events following vaccination with FLUZONE Intradermal. This reporter also reported another adverse event, which was captured in case number 2011-09901 and case 2011-09902. A group of 2 unidentified patients received an intradermal injection of FLUZONE Intradermal, sanofi pasteur Inc. lot number UT4163AA, on 06 October 2011. On 06 October 2011, both patients developed nausea and dizziness on the way home after vaccination. The nausea and dizziness continued the next day. The patients had swelling, redness and pain at the injection site. The outcome was reported as recovered for both patients. Documents held by sender: None.
death J18.9 - Pneumonia, unspecified organism K92.2 - Gastrointestinal hemorrhage, unspecified N17.9 - Acute kidney failure, unspecified
Starting in June , started to get intense hives almost every other day and/or swelling of the lip. Was prescribed an antihistamine as well as an epipen.
acute herpetic gingivostomatitis; queasy stomach, lack of appetite;  extra tired, groggy, felt not present, cloudy, distant; although no fever I felt quite hot around my face. Feeling not present was most severe for a few days.  Symptoms lasted until 6.30 Only treatment: rest, lots of water
After 30 min of getting rhe vaccination patient reported  L arm/L sequela/L cheek/ L lower limb flushing and so far as alternating between hot and cold. No SOB. Went to ED left AMA. Took Benadryl at gh's and sx were subsided. No weakness.
vision problems; moderately severe hearing loss; sensorineural moderate hearing loss; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or around 10-MAR-2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date in 2010 (reported as shortly after receiving the vaccine), he suffered hearing loss and was diagnosed with moderately severe hearing loss and sensorineural moderate hearing loss. The patient also suffered from vision problems after receiving the vaccine. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to vaccination. He also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events were determined to be disabling by the reporter. Upon internal review, the events of moderately severe hearing loss and sensorineural moderate hearing loss were considered to be medically significant.
Pharmacist called stating that at "28 or 29 year old" female patient stated that she only received one dose of GARDASIL 9 "at least a year ago." Caller stated the patient left before providing their name or any additional information. No additional A; No additional AE; This spontaneous report was received from a pharmacist and refers to a female patient 28- or 29-year-old. No information on patient's medical history, current conditions and concomitant medications was provided.   On an unknown date the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided) (inappropriate schedule of product administration and no adverse event).
back itches; rash on her neck and stomach; Occasional headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (back itches), RASH (rash on her neck and stomach), CHILLS (chills) and HEADACHE (Occasional headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was reported.     On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (chills). On 04-Mar-2021, the patient experienced PRURITUS (back itches), RASH (rash on her neck and stomach) and HEADACHE (Occasional headache). At the time of the report, PRURITUS (back itches), RASH (rash on her neck and stomach), CHILLS (chills) and HEADACHE (Occasional headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up information  received 05 May 2021 contains events recovered and a new event was added
Soreness in arm almost immediately after second dose, fever and whole body soreness night of. Face swelling, face hot to touch, rosecaea really bad. Next day had right eye swollen and very painful, vision compromised in thag eye. Day 3 had large internal stye in that eye. Never in my life had this happened. Day 4 back inflamed to where I can barely walk. Tired and weak for the next few days. On day 9 I woke up with a very sore throat and open sores in my mouth. I can barely chew anything this morning. In extreme pain, feel like my body is just swollen. I have been using ice, eyedrops, anvil, ibuprofen, heat for back, and mouthwash and saltwater for mouth. No insurance so I have not seen a doctor.
This spontaneous report was received from an office manager/medical assistant refers to an unknown number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies were reported. Since 03-DEC-2014 doses of PEDVAXHIB, which underwent supported temperature excursions, have been administered to unknown number of patients (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were reported. No concomitant therapies were reported. This is one of several reports received from the same reporter. Additional information has been requested.