chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting 2 hours after the injection- Moderate injection site pain and tenderness for 1 day.  Starting 18 hours after injection-  Severe Joint pain and moderate muscle pain for 3 days - unable to do normal tasks, slept extra, acetaminophen and ibuprofen only resolved the pain 20%. Pain Symptoms resolved upon waking on the fourth morning.  Starting 18 hours after injection-  Extreme tiredness for 3 days with moderate tiredness for additional 1.5 days.  It felt worse than when I had Flu B last year, but resolved  quicker.   Note: second shot given  4/16/2021 and outcome was much much less. Just moderate joint pain and tiredness and only for 2 days and ibuprofen resolved the pain 80%.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 05-MAR-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Initial unsolicited misuse report received from a nurse on 04-Nov-2015. This case involves a female patient and reported that a box of 10 prefilled syringes of FLUZONE (Batch number: UI498AA expiry date: 30-Jun-2016) stepped on and crunched. Most of the syringes were broken and there was a couple of shard of glass. It was reported that the nurse cut herself when opened the box. It was an accidental injury and syringe broken. Documents held by Sender: none.
Pt reports left arm was first sore, then increasingly swollen, then she developed a fever, felt dizzy(?), and "was sick all weekend."
pt recv vax 10SEP97 & p/vax pt cried inconsolably x24hr-temp 102 R;
This initial non-serious spontaneous case, was received on 03-Oct-2017, from other health professional, concerning a 68-year-old elderly male patient. The patient's medical history and medication history was not reported. On 03-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid muscle, batch number: 1620301, expiry date: May-2017, trade name, manufacturer: not reported). It was reported that last year's FLUVIRIN was administered to patient (explicitly coded as Expired vaccine used). Reporter stated that, the patient did not experience any adverse reaction. The reporter assessed this event as non-serious. Follow-up received on 12-Oct-2017: Reporter stated that, the vaccine was administered intramuscularly in the deltoid muscle of upper arm and confirmed that, the patient did not experience adverse reaction.
This patient had swelling, and redness of the left arm from above the elbow to the wrist.
Narrative:  Pt hospitalized with STEMI and reduced EF, occurred 12 days following 3rd dose of Pfizer COVID vaccine. Patient admitted, therefore reporting to VADERS.
the first dose of Moderna in the left arm gave me 18 hours of 20 minute intervals or rotating symptoms: 1) feeling burning pain in the left arm only 2) feeling nerve tingling as if I had bumped  my funny bone, but in the upper arm as well 3) general muscle soreness like overexercising 4) normal innoculation soreness, with only a little pain around the injection site. the second dose felt pretty normal at first: flu-like symptoms for the first 24-48 hours.   After about a week, I thought I had tendinitis in my left arm.  Growing soreness in all the tendons and muscles in my extremities as the summer wore on led me to believe I had a tick-borne infection, though testing showed that it was not the case.  It felt like I had tendinitis, and had just run a marathon (with no training) with my legs, and my arms felt the same ... all the big muscles, in the arms and legs, but not in the core, were experiencing this. My PCP recommended I see a Rheumatologist, as the pain had become unbearable by early September.  Despite not really using aspirin, ibuprofen, or naproxen sodium ever before, my daily usage was admittedly exceeding recommended dosages. A rheumatologist was not available until early October (6 weeks' wait?!?!), by which time, the pain had started to recede. I still, however, experience some daily pain, reaching for toilet paper, opening the fridge to get some butter ... normal everyday movements ... Yesterday before I showered, I brushed my teeth, and my right elbow sounded like someone was crumpling up a paper towel roll in there .. today, no sound.
Rash spread over body. Malaise - tired for 2-3 days. Felt malaise starting 10/29 vaccinated 10/28. Rash started on arm spread to body.
Fatigue, nausea, vomiting, fever, chills, headache, muscle aches. (All began immediately following 2nd dose and have continued to present day. However, as of 1/15/21 symptoms have begun to subside.)
Starting on about a week after I got the shot, I started getting dizzy. Not total vertigo, though I did experience some spinning a couple times. But rather a feeling like being on a boat. This has been ongoing for about a week. I have a history of vestibular issues w/2 major incidents of vertigo and ongoing feelings like I'm on a boat after an incident.   NOTE: I also had this after the second shot. I had a dizzy / on a boat feeling for about 3 weeks after the second shot.  Both incidents are not super acute, but the feeling is unsettling and makes me not want to drive or be in high stimulation environments.
Pt mom states pt screamed from 4PM p/shot given @ 3PM until 10PM; mom states pt would not stop screaming but for short periods & then continue again; mom did not call or seek med attention @ this time;
I experienced soreness, stiff arm, chills, joints and bones ached a lot. went to work but had to go home. had no energy, slept till next day. Had some hair loss. Chills and aches were gone after 24 hours.  I have developed lesions on my liver.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 3rd July 2018, the patient received the 1st dose of SHINGRIX. On 4th July 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, nausea, fever, tiredness, injection site swelling, injection site warmth and sleepiness. On 5th July 2018, the outcome of the injection site pain, injection site erythema, nausea, fever, tiredness, injection site swelling, injection site warmth and sleepiness were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, nausea, fever, tiredness, injection site swelling, injection site warmth and sleepiness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on the right arm. The next day, the patient experienced pain, swelling, redness and warmth at the injection site. The patient felt tired and slept all the day on 4th July 2018. She also experienced nausea and fever the day after receiving the SHINGRIX vaccine. The patient stated that by 5th July 2018, she felt fine again. The patient stated that, she mentioned the symptoms to her physician who advised that, she should not get the 2nd dose of the vaccine. The patient had denied permission to contact their physician.
7:00 pm-Malaise, headache, body aches. 3/9/17 AM- Denies sore throat. Arm red, swollen, hard, with unusual rash, no erythema or induration at injection site. Can't move arm well. Chills, fever (100.5F). Given acetaminophen and 1 g ceftriaxone injection in clinic. Home rx for cephalexin 500 mg BID x 7d. As of today (3/13/2017) redness/rash on arm is worse and coming in for another office visit.
Information has been received from a health professional concerning a 15 month old female with no known drug allergies and no significant past medical history who on 23 MAR 2001 was vaccinated with MMR. Concomitant therapy included streptococcus pneumoniae vaccine and diphtheria toxoid, pertussis vaccine, tetanus toxoid. On 02 APR 2001 the patient presented with a rash described as raised, discreet and erythematous. There were papules at the base and an area of palor like a halo. The rash was itchy and dispersed all over. It was reported that she also presented with a fever. Unspecified medical attention was sought. No other information was available. Another patient had a similar experience. Additional information has been requested.
general fatigue, body aches, soreness near the left clavicle area with a nodule/bump being the center of the soreness. Noticed approximately 24 hours after the vaccination.
fever, headache, diarrhea, nausea, chills. called in sick to work.
Information has been received from a nurse practitioner concerning a patient who on 24-OCT-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). The nurse reports the products were stored in the wrong spot in the office and varicella virus vaccine live (Oka/Merck) was given inadvertently. She does not feel that this was product confusion, it was a case of human error. No adverse events reported. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
10/28 at 1202 received PREVNAR. 10/29 at 0300 received DTAP - Hepatitis B - IPV (PEDIARIX). 10/29 at 1407 received PEDVAX HIB. On 10/28 was on room air, weaned off High flow nasal cannula at 1021 am, was on caffeine and had no events, on 10/29 am had some quick desats but self recovered and continued till 2043 when had apnea, bradycardia and desat which required PPV.
Started with a low grade fever a few hours after the shot, but the next morning it continued to rise.  By evening on 1/10/13 it was up to 103.6.  On 1/11/13 she continued to have a fever but it was low grade.  No other symptoms.  She saw a doctor on 1/10/13 to rule out any other cause of fever.
Red painful rash around injection site.  Very itchy. I called my doctor today to discuss the reaction I had and she advised me to go to the ER so it would be documented but I didn?t want to do that. I?ll seek medical attention if symptoms don?t improve in a few days.
Developed 9x7cm area of redness/swelling on left upper arm about 29 hours after receiving below vaccines.  No associated fever or anaphylactic symptoms but did have mild pain and itching of area.  Redness/swelling/itching occurred rapidly over the course of 1 hour per mom.
extreme swelling of chin radiating to neck w/large bump lt neck;gen malaise & achiness;3MAY96 peaked 4-5MAY96;13MAY swelling of joint lt ankle;
Patient passed out after administering the BOOSTRIX. She came to and then was in and out of consciousness multiple times. I used smelling salts to help wake her up and called 911. EMT came in and ended up taking her to the hospital due to not being able to get her fully stabilized after.
Injection site rxu described by patient's wife so not actually seen by us.  Described an almost blister - like rxu near injection site (no latex allergy) & area at site has had skin peel off.  Pt is currently applying NEOSPORIN ointment and keeping area covered.
Student fainted as per mother, was able to be aroused by nurse, oriented. R18, P84. EMS arrived 4 minutes later, student taken to ER. Student reports not eating lunch well and presently not feeling well.
Advised after getting first flu vaccine ever to sit and be monitored for 15 min. When told she could leave pt stated that she would stay awhile longer. Few minutes later, stated she was itching all over body. VS at 1:08 PM BP150/100, P 90 reg. BENADRYL 50 mg IM given. Breath sounds clear. 1:17 PM BP 146/98, P 80. Breath sounds clear, no wheezing, pt had small emesis. Pt in NAD=eg was sending and receiving text messages and conversing calmly and coherently. Refused epinephrine. Stated she thought she should go to ER and get SOLU-MEDROL. Transported to ER. Skin warm, dry, no color changes, no urticaria. Pt received BENADRYL 25 mg IM at ER, ZOFRAN 8 mg and SOLU-MEDROL 125 mg. Spoke with pt at 5 PM. Feeling fine.
On 3/21/96, the vaccinee received his 1st injection of Engerix-B (lot ENG1814A4). The vaccinee alleged that "During the weeks and months following vaccination, (he) developed a wide array of symptoms including severe pain in the feet, ankles and legs, arthritis, erythematous rash, fatigue, headaches and chest pain. Other more severe symptoms have gradually developed and appeared over time, including neurological damage and degeneration of the liver. Plaintiff has been completely disabled due to the onset of these conditions since 1997. On or about 6/28/00, (a physician) dx'd the Plaintiff's symptoms as arising from and constituting an adverse reaction to the Hep-B vaccination he received on 3/21/96."
I developed a headache within minutes of injection; however by 6 pm my arm at the injection location was the size of a baseball and hot to touch. I took Tylenol and ibuprofen at 6 pm on day of injection (Day 0). On Day 1 I took Tylenol and ibuprofen in the morning and evening injection site size of tennis ball and warm to touch. On Day 2 I had Tylenol and ibuprofen just in the morning site still size of tennis ball and warm to touch.  Day 3 no medications site size of golf ball and warm to touch.  Day 4 and today (Day 5) no noticeable swelling, no medications. Oly quarter size area is painful to touch. No temp difference noted.
Began with headache. Proceeded to get fever with chills. Headache worsened over night. Nausea occurred as headache persisted
The patient had her second Moderna shot on Feb 17, 2021. At 3 am the next morning she reported to the ED c/o being "fluish" and short of breath. She was found to be hypoxic to the upper 80's on RA, and a CXR was consistent with CHF.  She stated she had some off and on chest pain for the last few weeks, especially with exertion. Ultimately it was found that she had an elevated troponin and was felt to have had an MI. She underwent cardiac cath and a stent was placed in a 95% ostial right coronary stenosis.   Although she was reported as having had a "hyperimmune" response to the vaccine, I can only say for certain she had flash pulmonary edema due to cardiac ischemia that was due to a stenosis in her RCA that had been there for quite some time, but possibly just happened to become critical right after her second COVID vaccine. It would be hard to blame the vaccine, but it is also impossible I guess to absolve it from any role in her MI.
About 20 minutes after injection Itching in throat and cheeks. Bumps in back of throat present. Alert, speaking in full sentences, sensation did not worsen. Gave 25mg Benadryl and symptoms improved.
Anemia; This non-serious case was reported by a consumer via call center representative and described the occurrence of anemia in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced anemia (Verbatim: Anemia). The patient was treated with blood transfusion, auxiliary products (Blood Transfusion). The outcome of the anemia was resolved.   It was unknown if the reporter considered the anemia to be related to Shingrix.     It was unknown if the company considered the anemia to be related to Shingrix.   Additional Information: GSK receipt date: 08-May-2023 The patient received the Shingrix 5 year ago from reporting. The reporter stated that the patient received a blood transfusion a year ago from reporting due to anemia.  The patient recovered from anemia.  The reporter did not consent to follow-up.  The reporter did not give permission to contact healthcare professional. No other information known.
I broke out in a face rash. It started at my chin and went up my jaw lines. Was dry and itchy. No lotion or creams I tried work. It finally went away on its own in about a week.
Brachial neuritis. Started as pain at vaccine site but by 2 PM was numbness of arm and hand. Seen at 7 PM, numb forearm and hand.
Patient  requested a Shingrix vaccination and was given a dose. However afterwards we found out the patient had already received  the 2 dose series back in 2018/2019.
Itching, @2 inch red rash at injection site. It?s been this way for @24 hours
Pt was vaccinated approximately 9:30am without difficulty and well tolerated. acetaminophen given prior to vaccine and again at 7:30pm. Temp taken 8:00pm with reading of 103.1F approximately 8:30pm pt had the 1st grand mal seizure lasting for 2-3 minutes & the 2nd occurring in the car on the way to KDMC ER lasting 1.5 minutes. Tests run & spinal tap performed to rule out meningitis. Pt given A-Cillin and discharged.
Lightheadedness, increased sweating, fatigue, chest pain, easier fatigue from exercise, heat and cold intolerance, blurred vision, numbness in hands and feet, lightheadedness upon standing
For the vaccines MMR/Varicella, Influenza and DTaP+IPV there were multiple listed and Im not sure if they were the correct manufacture, The drs office would have that information.  Patient had her vaccines on a thursday morning, Saturday morning I noticed facial drooping on the left side. I have a family member that specializes in strokes that immediately checked patient and said it looked more like Bells palsy . I took patient into see her PCP and he verified that she did have Bells Palsy but didnt think it was related to her vaccines. patient was given prednisolone for 10 days.
Vaccine given on 11-11-10, four days later on 11-15-2010 mother noticed rash to child's face and extremities (arms). Abdomen also with urticarial rash. Child seen in office on 11-15-10 at 11:16am and diagnosed with ? egg allergy. Referral made to an allergy. Medication treatment with steroids.
Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 18th February 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and had a sore arm for approximately two days. Thereporter did not consent to follow up.
Horrible feeling; Cant feel down her feet; Itchy skin; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Horrible feeling), HYPOAESTHESIA (Cant feel down her feet), PRURITUS (Itchy skin) and PYREXIA (Fever) 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 FEELING ABNORMAL (Horrible feeling), HYPOAESTHESIA (Cant feel down her feet), PRURITUS (Itchy skin) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Horrible feeling), HYPOAESTHESIA (Cant feel down her feet), PRURITUS (Itchy skin) and PYREXIA (Fever) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medication details was reported.  No treatment medication details was reported.
Patient received her vaccines and did not wait the recommended 15 minutes at the office.  At ~10:30 upon reaching the parking lot patient suffered brief syncopal episode per mom's report.  No fall or injuries sustained.
At about 2am the morning after vaccine, I woke up and was having chills. Arm was extremely sore, hot, and swollen. I had a headache, nauseous, and just not feeling well at all. The next morning when I got up for the day I was dizzy and was running slightly over 100 fever. Head was killing me and aching all over. Tired and lethargic went back to bed for the rest of the day. Maintained 100 fever through out the day. Arm pain continued to hurt and get worse. The following day my fever stay around 99. Still achy, fatigued, and had flu like symptoms. Symptoms are improving but still experiencing fatigue on 04/13/2022.
Pt stated she developed swelling and cellulitis at the site of the injection, was given oral antibiotics and after taking one tab of the antibiotics went to the Emergency department for IV antibiotics as the oral antibiotics weren't working.
Initial report was received 14 October 2011 from a health care professional which involved a cluster of two patients. This case captures one patient. The other patient has been captured in case number 2011-10152. An elderly female patient had received an injection of FLUZONE HIGH DOSE, lot number UT457AA and an unspecified amount of time later, the patient went to the emergency room (also reported as hospitalized). The adverse event experienced by the patient was not specified. No additional information was provided at the time of the report. Outcome was not reported. Documents held by sender: None.
Nine days after my first Pfizer shot I woke up to a spinning room. The dizziness lasted for 1-2 hours. Two days later I developed an outer ear infection in my left ear. I have never had an ear infection in my life before. I was given antibiotic drops with steroids for treatment and that made it better.   My second shot was much worse. I felt heat in my stomach minutes after receiving it. The injection site was swollen and painful for the next few days. The bad side effects started about 24 hours after the second shot. I experienced: severe vertigo, feelings of sinking floating, tilting. Complete loss of appetite. Inability to sleep. Feeling like I was being zapped at random times. Derealization and depersonalization. Brain fog. Forgetfulness. Extreme fatigue with inability to rest. Lump in my throat. Brain surge (feeling like my brain was flooded with heat or water). A lot of balance issues. Burning in arms, back, chest. All these brought on panic attacks which only made the original symptoms worse.
First GARDASIL given 5/11/09. She called my office on 6/17/09 to say she had itching in her fingers and water blisters after inj. She gets same rxn when exposed to sulfa.
Injection site reaction included pain, soreness, warmth, redness, and a hard lump
Initial misuse report received on 10 October 2013 from a nurse. A patient whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that a patient received FLUZONE ID.  As of unknown date, patient was adm to a 60 years old. No safety or immunogenicity under 65. Review PI for AER that occurred in the cl trials. List of documents held by sender: none.