chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacy student, regarding an adult patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with two pediatric doses of RECOMBIVAX HB (strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. However, no adverse events were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1710USA001050.
Pt. got the MMR/Varicella/Hep A #1 on 1/25/19. Pt. has started with insect bite mark lesions on 2/2/19 back; (R) cheek; 2/3: (L) thigh on site of varicella shot without induration and tiny papules 2" x 3/4". 2/4/19: New one on (R) medial thigh/upper lip/forehead/2 fingers/chest.
This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (potential UTI) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included UTI (the patient had them occasionally in the past.).    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced URINARY TRACT INFECTION (potential UTI). At the time of the report, URINARY TRACT INFECTION (potential UTI) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was going to see the doctor at the time of the report. No concomitant medication details were provided. No treatment medication details were provided.    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: TCR-Non significant info
I had issue with Equilibrium off Dose 2, Moderna, 02/5/2021. I began to feel tired, then dizzy and went to bed. Next day felt weak and tired and slept it off and by Sunday I was feeling better and on Monday my health resumed to normal.
1/18 developed fever (100.1) in evening along with poor appetite. 1/19 pale complexion before bed. 1/20 woke up with flu like symptoms 3:00am, very pale, diarhea, vomiting, high fever (102.5) all day.  Pale complexion, diarhea, intermitent fever, and poor appetite lasted through 1/24.  Developed fever(102.5)again on 2/3 & 2/4.  Polio & DTap vacc. mfg. was SANOFI
fever of 99.5 degrees Farenheight; flu symptoms; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 99.5 degrees Farenheight), INFLUENZA LIKE ILLNESS (flu symptoms) and MYALGIA (muscle aches) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced PYREXIA (fever of 99.5 degrees Farenheight), INFLUENZA LIKE ILLNESS (flu symptoms) and MYALGIA (muscle aches). At the time of the report, PYREXIA (fever of 99.5 degrees Farenheight), INFLUENZA LIKE ILLNESS (flu symptoms) and MYALGIA (muscle aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Body temperature: 99.5 fever of 99.5 degrees Farenheight.         no concomitant medications are provided. treatment to the events not  provided. Action taken with mRNA-1273 in response to the event was not applicable
He was very tired and quit the same day after the vaccine and woke up already next morning 6/12/2019 about 8am with "abnormal involuntary movements" that looked like seizures, dystonic movements. He extended his upper and lower extremities and they stiffened and started to shake. Noticed 10-15 episodes a day right after the vaccine and increased to 50-100 a day. All these resolved after 5 months. He had these episodes non stop. He also stopped smiling and "babbling" like before. During this episodes, he seemed like having "pain" in his brain. Visited his pediatrician and on 6/14/2019 he was admitted to ER since the episodes were increasing.
Patient reports severe arm pain radiating down to elbow and up to neck. Patient reports having difficultly moving arm.
Swelling underarm in arm pit painful Started the morning after injection. Continued to worsen over next five days contacted dr office today-(day 5) they said take ibuprofen 600mg 3x and recontact tomorrow.
1. Pain at injection site x 48 hours 2. Arthralgia, both shoulders, both knees > 1 week
About 5 hours after being vaccinated, Patient had a high fever that wouldn't go away that would go back and forth from 103.0 to 104.0 degrees. She had non stop tremors, couldn't sleep, couldn't really talk, and children's medication barely helped, if at all. This always happens to her and it takes her at least a full 2 or more days to recover. We contacted the hospital as usual and they stated like they always do that this means her "immune system is working properly" and to keep her hydrated, give her lukewarm baths, and use a cool compress on her head.
Fatigue; Massive headache; Aches; Fever; This case has been considered invalid: no first-hand knowledge of adverse events    This is a spontaneous report from a non-contactable consumer. This consumer reported for a 44-year-old female patient that:  I learned from a friend yesterday that her friend had told her through text message that she experienced side effects as a result of the second dose of the Pfizer COVID 19 vaccine.   As an employee of Pfizer, I know it is my responsibility to report side effects and learned of these during a meal. The report came up during conversation.   The patient, 44 you F, received Pfizer vaccine at her work and reported the following side effects via text message:  "Felt great after first dose, second dose, rough, fever, aches, massive headache, fatigue."  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient presented to the Pharmacy on 10/15/2021 for flu vaccine. She was given a COVID vaccine instead. (this was a 3rd dose for her). Previous COVID vaccine was given 06/23/21 and 07/14/21. Seen in ER 10/16/21 and 10/22/21 w/ c/o Headache, Chest pain, dizziness, myalgia, fatigue.   CXR,EKG,CT scan - normal .. Seen in  our office 10/25/2021 - c/o fatigue HA, muscle pain.- CBC, Pt.PTT, CMP, ESR CRP and EKG
3/10 One day post vax, patient experienced fever and convulsion. Was admitted to hospital and released 3/11. Child remained well until 3/14 when he experienced fever and convulsion. Was hospitalized again. Evening of 3/14, he experienced convulsion in hospital and remains hospitalized to date. Mother states that child had diarrhea and illness for about one month when her physician stated on 3/8 that he was well and could receive vax. Follow up information received 7/18/00 stating that during childs hospitalization, he was given generic Valium PRN for fever to prevent seizures. He also had an ear infection 06/2000, and was prescribed medication but has recovered.
Cough  Shortness of Breath  Difficulty breathing  Congestion or running nose
Site injection pain within couple of hours,  pain in arms- hands - feet - legs within 6-7 hours, fever/chills-headache-tiredness within 8 hours ,muscle weakness 24+ hours
A serious study report of tonsillitis and obstructive sleep apnea was received from a study investigator, concerning a four year-old female patient (patient 56398710) enrolled in post marketing study. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 year to 59 months of age for FLUMIST. Medical history includes tonsillitis and obstructive sleep apnea diagnosed on 14-Aug-2007. The patient also has a history of urticaria. Patient was not on any concomitant medication and has no known allergies. The subject is in daycare and gets frequent colds. The patient received FLUMIST on 12-Nov-2007 for influenza immunization. The patient was hospitalized on 26-Nov-2007 for tonsillitis and obstructive sleep apnea. Tonsillectomy and adenoidectomy were performed and were well tolerated. The patient recovered and was discharged on 27-Nov-2007. The events were considered mild. The patient reported pain a week after procedure and subsequently the pain medication was increased and was advised to increase fluid intake. The investigator assessed the events as not related to FLUMIST.
This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not provided. On an unknown date, the patient was vaccinated with (Oka/Merck) (manufacturer unknown) (lot number, expiration date, dose, route and anatomical location were unknown). There was no concomitant medication reported. On an unknown date, the patient was diagnosed with varicella. According to the reporter, two doses of vaccine are required for attendance in all state schools. At the time of the report, the outcome of varicella was unknown. The reporting nurse did not assess the causal relationship between the adverse event with the varicella virus vaccine live (Oka/Merck) (manufacturer unknown). Additional information has been requested.
fever to 103R, indurated site of inject, unconsolable for 24 hrs p/vax; onset approx e hrs p/vax;
Pain in the arm injection was administered in. Swelling, redness, and warmth surrounding injection site with tenderness upon palpation.
Complaining of chills, nausea, vomiting, "worst headache of my life" sensation, fever, hypotension.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about in 2016, the patient was inoculated with ZOSTAVAX by a physician as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about September 2016, the patient was treated the physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Development of shingles along the waistline. Never had chicken pox nor shingles in my life. Only received the chicken pox vaccine and Moderna c19 vaccine.
Patient became very pale, sweating profusely, nauseous, described fluttery/pins feeling in feet, legs, and hands, on the verge of losing consciousness within 10 minutes of administration of the injection. Patient was offered cool sips of water and orange juice by mouth, explained they had not eaten, yet, that day, though replied negative to being diabetic. BP and heart rate checked out normal. Patient remained at administration site for an hour after injection before being able to depart under own power. Partner drove them home.
pt recv vax 14AUG98 & the next evening child mom reported that child had devel an inj site rxn;17AUG98 child was seen by MD who noted a 3.5 to 4inch area of redness & warmth @ the site of acel-immune administration;MD prescribed DPH;
Dr. Ordered Tdap vaccine to be administered.  Medical Assistant administered DTap by mistake. GSK vaccine company contacted regarding error and they will file report as well.  Patient suffered to adverse reation from the DTap and had no previous reaction from her infant shots. No further vazccination is necessary per the CDC. Next vaccine would not be due for 10 years.
Patient received Pfizer COVID vaccine on 3/12/21 and 4/2/21. On 2/5/22, patient admitted to our inpatient facility with recurrent syncope, UTI, and COVID infection. As of today (2/7/22), patient is still admitted in the med/surg unit.
Initial report was received from a healthcare professional on 05 February 2013. A male patient (age and date of birth not reported) had received an intradermal injection of FLUZONE Intradermal (lot number, site and date of administration unknown) and an unspecified amount of time later experienced swelling of the lips and hands. Outcome was not reported. Documents held by sender: None.
My husband has had a fever and extreme exhaustion every day, all day. for 16 days, since he go the Pfizer vaccine. He is retaining water, does not sleep at night, has heavy night sweats, and is emotionally spent. He has no appetite and forces himself to eat. He tastes what little food he eats. He visited his family doctor, a gastroenterologist, and has been in the emergency room two times for sheer exhaustion and pain. He was released both times after tests. Each time, no one could find a cause and no one sent him to other doctors for help. They would not admit him because there was no guarantee he could see other doctors any faster than if he were at home making appointments. He was referred to an infectious disease specialist by the gastroenterologist, but that appointment  isn't until March 9, 2021. He will have faded even more by then.
Vaccine 11/4/09 to right arm. 1 month later had to be seen in ED for "stroke like symptoms". Dx with peripheral vertigo and referred to PCP. PCP Dx=Vestibular Neuritis.
11/07/08 at 956 am - Patient return to the office with much erythema and tenderness to right shoulder at Td injection site. Exam: 10 cm x 6 cm at injection site with central induration and tenderness. Treated with KEFLEX 500 mg QID x 7 days and DEXAMETHASONE 4 times daily x 4 days.
Widespread joint and muscle pain about 36 hours after my second vaccine. Fatigue was overwhelming. The pain in all my joints, muscle ache and fatigue have continued since that time.
Spontaneous Urticaria- Severe random itching of the skin. Arms, legs, feet, chest, neck, back. When scratched, small red bumps appear as well as dermatographia. Resistant to anti-itch creams. Menstrual period was also 2 days late with 3 days of cramps before the period started, which is unusual for me. It also only lasted 3 days, when it is normally 5.
Red welts began appearing over back, arms, neck and face. Each welt is raised and ranges in size from 1.5 to 2.5 cm in diameter. They are raised and itchy and one involves the eyelid. (It is possible this is the evolution of an independent upper respiratory viral illness that is concurrent).
Displayed some coughing, headache, and muscle aches.  Given a prescription for Paxlovid.
The initial reaction was body aches and then I started having headaches. I would feel behind both eyes I could feel my heartbeat. I started to exp blurry vision in both eyes. I would get a sensation in my head and radiating pressure after sneezing or laughing lasting 10-15 secs. I seen my opthamologist and  neurologist for my adverse events.
Pain immediately upon injection. Severe tenderness, achy pain, swelling from shoulder to elbow within 2 hours. By 3 hours, unable to lift arm. Severe nausea difficulty breathing. Arm red, feverish to fingers. As of 12/16/2001, persistent joint pain/ache, but swelling better.
Very irregular menstrual cycle. Spotting for two weeks followed by complete disappearance of cycle. Spotting started about 7 days after initial dose followed by disappearance after second dose.
2 weeks of heart palpitations from 4/25/2021 - 5/09/2021. They seem to have subsided as of 5/10.
Patient waited outside in recovery area for 15 minutes. Patient complaints of her throat being in pain and feeling pressure.  Patient stayed for an hour since her vaccine.  Her pulse ox was checked at 10:00 am and it was 97 % , she was calm and able to speak full sentenced.  Her pulse ox was checked at 10:15 it was 99% and pt was calm and able to communicate. Pt communicated that pressure was going away. Pt was sent home at 10:50 and recommended to seek medical attention/ call 911 if there is any breathing difficulties.
PER PT ON THE EVENING OF 8/31/20 PT EXPERIENCED SEVERE ARM PAIN AND ACHE FELT NAUSEOUS, FOGGY AND NOT 100 %. WAS ABLE TO EAT AND DRINK LIQUIDS. THE SITE OF INJECTION WAS SWOLLEN. FELT COLD, WAS SWEATING HAD CHILLS AND FLU LIKE SYMPTOMS. HAD A FEVER OF 99.7. SYMPTOMS LASTED UNTIL FRIDAY AND EARLY SATURDAY. ON THURSDAY 9/8/20 AFTER DINNER HAD STOMACH ACHE AND CRAMPING. FELT SENSITIVE AND PRESSURE OF FIST LIKE PAIN TO THE STOMACH THAT WAS CONSTANT. TOOK OTC MOTRIN AND APAP FOR PAIN AND FEVER.
I had left arm pain that included numbness in my left arm and my elbow. I had a growth that began on my left arm and was diagnosed with squamous cell carcinoma, I had it removed August 2021. I also had left jaw pain. I have TMJ but this was new type of pain. I began having vaginal bleeding even though I am post-menopausal. I saw my gynecologist. I was intrauterine lining build up I had to have a DNC on August 30, 2021. Within 24 hours after surgery, I had a Bell's Palsy attack on my left side of my face. I was paralyzed for 6 weeks on the left side of my face. I now have chronic neurological damage on the left side of my face. I have damage to my tear duct and to my sinuses. My eye waters every time I chew, crocodile tears.
Fatigue, muscle soreness primarily at shoulders, upper back, neck & abdomen, L worse than R. Chills but no fever.
Breakthrough case admission after 2 vaccines' Pfizer 1/29/21 Lot# EL3247;  Pfizer 2/23/21 Lot# EL9267
Sore arm, bad headache, chills, sore muscles, fatigue within 24 hrs
Severe chest pain, shortness of breathe, difficulty breathing, lasting for 10 consecutive hours. Moderate chest pain continued for 48 hours. Fever and cold sweats that lasted for a few days.
concerned; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A non-contactable female consumer reported for herself.  A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot/Batch number: unknown) via an unspecified route of administration on an unspecified date in Feb2021 (last week) as single dose for COVID-19 immunisation. The patient's medical history included allergic reactions to sulfa, prednisone/cortisone, penicillin, codeine. Concomitant medications were not reported. The patient stated that she was very concerned about receiving second dose. She was more concerned about having a fast heart rate or allergic reaction. The caller reported that she had no side effects from the first vaccine and was not concerned about minor side effects like fever, chills and body aches. The caller stated that she read online that people with penicillin can have a bad reaction to the vaccine. The caller was asking whether she can be totally okay with the first shot, and then have a severe allergic reaction for the second vaccine shot. Caller was also asking whether she can stay at the vaccination clinic longer than 30 minutes and wanted to stay all day to make sure she doesn't have a reaction. The outcome of the event was unknown.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
patient with no spleen was prescribed Bexsero by the treating doctor; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 74-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Concurrent medical conditions included asplenia.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced intercepted drug prescribing error (Verbatim: patient with no spleen was prescribed Bexsero by the treating doctor). The outcome of the intercepted drug prescribing error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 4 August 2023 The pharmacist inform that a 74-year-old patient with no spleen was prescribed Bexsero by the treating doctor which led to intercepted drug prescribing error. The reporter consented to follow up.
Child spiked a fever, was hospitalized, endured a spinal tap. Was never given a reason, Dr.'s said it must be a virus. These same events took place 4 weeks prior with the first Hep B vaccine. That time the reaction took place 2 weeks & 6 days after.
Patient complained of mild headache 15 minutes after injection and mild dizziness. 30 minutes after injection complained of right face numbness, right ear and right neck pain. Evaluated 1 hour later and denied symptoms
Diagnosed with positive COVID-19 a couple of days after receiving the Moderna COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with positive COVID-19 a couple of days after receiving the Moderna COVID-19) in a 79-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced COVID-19 (Diagnosed with positive COVID-19 a couple of days after receiving the Moderna COVID-19). At the time of the report, COVID-19 (Diagnosed with positive COVID-19 a couple of days after receiving the Moderna COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
received Fluarix after expiration date; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 5D4H4, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. In October 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received expired dose of Fluarix QV, which led to expired vaccine used.  The reporter consented to follow up by email.  No details from patients involved were available. This is 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021211492:same reporter US-GLAXOSMITHKLINE-US2021211489:same reporter US-GLAXOSMITHKLINE-US2021211495:same reporter
I had sniffles, chest congestion, coughing, and fatigue. I tested positive for COVID-19. I went into an urgent care, and they prescribed me PAXLOVID. I still have fatigue and brain fog but I feel better.
Headache, dizziness, left side of her jaw locked up, and back spasms.