chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6AUg98 reports 3"x3" induration, bright red & extremely warm to touch lt upper arm (site of Td inj) fever 101 orally throughout day;took APAP;7AUG98 induration;12AUg98 1" x 3/4" induration & sl dark red;c/o muscle soreness;
23 month old patient received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 23-month-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th July 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 5th July 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 6-July-2022 Reporter's comment: The reporter reported that a 23-month-old patient received Kinrix. The reporter consented to follow up. Additional supportive information: The 23-month-old patient received Kinrix which led to inappropriate age at vaccine administration.
I got the shot Thursday Oct 28 at 1400. The symptoms didn't hit until 1930 the same day.  Deep intense muscle aches - felt like I was being kicked and punched repeatedly Struggled to sleep because of the pain Whole body weakness, unable to move around. I was able to move from the bed to the bathroom and back to bed Body temperature fluctuations - I was always going between freezing cold and shivering to overheating with profuse sweating. Lack of appetite Temporary Blindness - lasted a few minutes around noon. It came on suddenly without warning then slowly came back.  Slept all day Symptoms lasted 24 hours. After 24 hours I was able to finally get up an eat a little bit of food (Friday October 29 at 1930). By day 2 (Saturday) I was still very weak but wasn't bed ridden as much. I was able to get up and move around do minor house hold chores. Didn't feel comfortable enough to drive until Sunday (Day 3).
No immediate reaction. Patient-reported deceased four days later on Jan. 19, 2021. As of this date cause of death is unknown to our clinic.
acute COVID; acute COVID; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Nov2022 as dose 5 (booster), single (Lot number: GH9697) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Inflammatory proctitis" (unspecified if ongoing); "Known allergies: Sulpha" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "acute COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2023) Positive, notes: 3 days after first negative test; (Mar2023) Positive; (Apr2023) Negative, notes: day 8. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 29Mar2023 to 03Apr2023.  Clinical course: Had acute COVID, and became negative day8 and symptoms resolved. Symptoms returned 3 days after first negative test and antigen test became positive again.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
fever; felt lousy; swollen lymph nodes; sick; body aches; had chills; Headache; gastro-intestinal issue; Felt very terrible; it re-triggered the smell of cigarette smoke; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8727) via an unspecified route of administration on 20Mar2021 17:00 (at the age of 56 years old) as dose 1, single for COVID-19 immunisation. Medical history included high blood pressure, have one kidney, COVID-19 infection (COVID-19 infection 11 months ago). No investigation assessment. Concomitant medication(s) included lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported, blood pressure medicine and small water pill 2.5 mg. The patient experienced fever, felt lousy, swollen lymph nodes on 21Mar2021 11:00, sick, body aches, had chills, headache, gastro-intestinal issue, felt very terrible, it re-triggered the smell of cigarette smoke on Mar2021. Reported as, patient had the Pfizer COVID vaccine first dose last Saturday 20Mar2021. She had all the classic symptoms. She felt very very sick after the first dose, have not had the 2nd dose (scheduled for 10Apr2021). she had almost all the side effects: fever, body aches, felt lousy, had chills. She have 1 kidney and also had COVID-19 eleven months ago, have the antibodies already. She got pretty sick with the first. Patient was concerned about getting second dose of Pfizer-BioNTech COVID-19 Vaccine because of having one kidney. She had it like 5 PM and then the next day Sunday at 11 AM she started to have all the classic side effects including a fever and pretty much everything and she do not know if have swollen lymph nodes but she have everything else. She had Covid 11 months ago and she had tested and had the antibodies and everything so she felt pretty lousy last Sunday. She had 100.9 F body temperature, body ache, headache, chills, gastro-intestinal issue. She mentioned she tested COVID-19 eleven months ago where she was able to smell cigarette smoke even no one was smoking around and that she lives alone. She said that the first shot made her feel worse and after few days, it re-triggered the smell of cigarette smoke. Treatment included Tylenol. The patient underwent lab tests and procedures which included body temperature: 100.9 fahrenheit, sars-cov-2 antibody test: positive, sars-cov-2 test: positive (had COVID-19 eleven months ago), all on unspecified date. Outcome of all the events were unknown.  No follow-up attempts are needed. No further information is expected.
headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) 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 HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
severe shoulder pain , tingling in fingertips all the way up my right arm to my neck on the right side. woke out of a dead sleep at 130am with no range of motion of my right shoulder . pain was 10/10 . was seen in my clinic by ANP
Some itching; Second shot was more painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Some itching) and VACCINATION SITE PAIN (Second shot was more painful) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery in May 2020.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Some itching) and VACCINATION SITE PAIN (Second shot was more painful). On 26-Feb-2021, VACCINATION SITE PAIN (Second shot was more painful) had resolved. On 27-Feb-2021, VACCINATION SITE PRURITUS (Some itching) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-059885 (Patient Link).
pt devel pox p/vax, inj site soreness, redness, swelling, rash, itching & gen rash;pt was treated w/med;pt recv 2nd vax 27JUN96 w/o a problem;
This spontaneous report was received from a physician referring to an adult patient of unknown gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with PROQUAD (Merck) (strength, dose number, route, anatomical location, lot number and expiration date were not provided). Concomitant therapies were not provided. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Patient was given Influenza Fluzone High Dose Quadrivalent vaccine which is labeled for 65 years and older. However, patient is only 63 years old. No known symptoms or signs at the time of submission of this report.
Left upper arm local allergic rxn w/ redness and edema approximately 5-6 cm diam. where flu shot given yesterday.
10-5-2012 PM - (L) arm sore. 10-6-2012 barely able to raise (L) arm. 10-7-2012 101.6 (O) redness, edema. 10-8-2012 12:00 - entire deltoid red, swollen, hot to touch fingers tingling ice pack applied axilla red.
This report described the occurrence of heaviness of the leg of a female pt who received Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis.  This report was received as part of litigation proceedings.  The pt received injections of Lymerix on 04/22/1999 and 05/20/1999 "according to the client".  On 09/03/03, the pt's attorney alleged that the pt "suffered heaviness of her leg and severe right hip pain beginning within several weeks of her second vaccination according to the client".  Treatment and outcome of the alleged events were not reported.  The following information was obtained from medical records forwarded by the attorney on 12/03/03.  This 46 year old female was an avid runner.  She developed right hip and thigh myofascial pain and lower back pain for the first time while running on 05/09/1999.  The pt reported to her physician that the pain worsened after she received her second vaccination of Lymerix.  She underwent chiropractic treatment and massage therapy to treat the ongoing pain.  She saw her physician on 05/03/02 and, since the pain was continuing, was referred for physical therapy.  After sixteen physical therapy visits from 05/09/02 to 06/20/02 she made good progress in controlling the pain, though for two to three weeks during the therapy she did not run at all.  Her rehabilitation physician noted that her symptoms were consistent with osteoarthritis of the spine and hip.  He recommended increased cushioning of her footwear and decreased frequency of running sessions. At a follow up visit to her physician on 06/28/02 she was doing better and had continued her running activities.  During the period after she received Lymerix she sought treatment for recurrent attacks of epigastric pain.  She had a long history of heartburn and, on 11/05/01, was in the process of being worked up for these episodes.  The epigastric pain was not reported as an adverse event due to Lymerix administration and is not coded as such.
Second dose - right arm - large red patch developed at vaccine site 1 day after vaccine and is only now beginning to fade ((6 days after vaccine); red patch was warm to the touch.  Bad bruising sensation, although no appearance of bruise, other than red patch; bruising sensation ended 4 days after vaccine.  Possibly coincidental, but subconjunctival hemorrhage appeared in top inside corner of right eye 3 days after vaccine and is still spreading in eye today (6 days after vaccine). First does - left arm - no adverse events other than muscle stiffness at vaccine site for about 3 days.
Extreme drowsiness with slight headache 4 hours post shot.   Went to bed at 10:30pm and woke up at 8:30am next morning. Injection site was fender and slightly swollen and i flamed. Over a period of 8 hours, the site grew more painful and swollen. Approx 2 in by 2 in,  welt formed around injection site. Painful to touch and slight itch, bad headache through entire day, particularly behind right eye. Injection was in tricep area on right side.
Itchy, red rash, widespread >50 erythema vesicles. Dx: varicella. Tx: symptomatic.
The pain started five minutes after the injection, I know because I checked my watch, I was timing out the 15 minutes I had to wait. The pain didn't live me for 12 days. At one point I was taking percocet with acetominophine in the highst dose I was able to take, it barely touched the pain. I woke my self up screaming in the night when I tried to move my arms. The pain so so intense. It was like I was tearing the muscles to be able to move.  After twelve days of extreme all over body pain it finally eased. Then it moved on to headaches. Ringing in the ears. And all my interal organs feel swollen and tender. I feel  of pain and discomfort when I eat.  I will have my second vaccine on the 6th. I spoke to a PA about my symptoms while there with my housemate. The PA felt that while my response was extreme, it would probably pass with time.
Client reported chest tightness and a decreasing heart rate. The client reported a declining HR based off an app on his phone. The client also reported feeling hot and cold. The client ambulated unassisted and sat down in an anti-gravity chair. Reclined the anti-gravity chair with the client seated. The client denied any shortness of breath. Vitals obtained at 5:12 PM were as follows: automatic BP 149/88, HR 53, O2 98%. The client denied any chronic conditions. The client does not take any medications regularly. The client has an allergy to Tramadol where he reports a rash on his face. The client also reported dizziness. The client stated he has been drinking water throughout the day and ate at about 1 PM. At 5:14 PM the client denied any other s/s of anaphylaxis. The client reported mild persistent dizziness and was still feeling hot and cold. The client was provided a cool pack on the back of his neck. The client stated "I feel my body shaking" like "shivers." The client denied any numbness in his hands bilaterally. Vitals obtained at 5:14 PM were as follows: HR 58, BP 144/98, O2 98%. The client denied any persistent chest tightness at that time. At 5:12 PM the client stated "I feel much better." The client then reported feeling "sleepy." The client was alert and oriented to person, place, time, and situation. The client stated he drove himself today, but lives about 3 minutes away. Vitals obtained at 5:23 PM were as follows: HR 57, O2 97%, and BP 150/93. The client stated he does not know his regular BP. Manual HR obtained by RN was 50 BPM. Radial pulse 2+ bilaterally. Vitals obtained at 5:28 PM were as follows: HR 51, automatic BP 151/95, O2 98%. Asked if the client felt sleepy and he replied "not too much." The client denied any other s/s of anaphylaxis. The anti-gravity chair was adjusted so the client was sitting upright. Repeat vitals obtained at 5:30 PM were as follows: manual BP 130/80, and manual HR 60 bpm. Educated the client regarding s/s of anaphylaxis and when to seek EMS. Recommended the client follow up with PCP regarding BP. The client voiced understanding of this education. The client stated he felt safe to drive home. The client denied any persistent symptoms. The client stood up unassisted. The client left the vaccination site unassisted with a steady gait.
Pt was given Hep A #4 one month after receiving Hep A #3. Pt is repeating the series because of not showing antibodies.
headache, still persisting 3 weeks later, reports smelling cigarette smoke consistently even though no one smokes in house.
Had normal fever and injection site pain on 2/12. 2/13-14 the fever was gone, but arm pain persisted. (After first dose, pain only lasted one day). 2/14 a large red lump appeared around the injection site, and itching began. Today, 2/15, pain is mostly gone, but red spot and itchiness persist. I'm not reporting because these are terrible side effects or were totally unexpected. But I don't find other reports of similar reactions, and I want to make sure this is okay.
After patient received the vaccine while waiting 15 minutes, the patients blood pressure dropped. The patient fainted and hit his head. He was conscious during the event. The EMS was called and they check the patient. The patient was offered and opportunity to go to the hospital but he declined.
patient with tinnitus states he felt the ringing got louder after receiving first dose/ progressing of tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (patient with tinnitus states he felt the ringing got louder after receiving first dose/ progressing of tinnitus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced TINNITUS (patient with tinnitus states he felt the ringing got louder after receiving first dose/ progressing of tinnitus). At the time of the report, TINNITUS (patient with tinnitus states he felt the ringing got louder after receiving first dose/ progressing of tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
have been vaccinated and had shingles / Suspected vaccination failure; I had shingles; have been vaccinated 3 times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, not applicable after receiving Shingles vaccine and unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had shingles and had been vaccinated 3 times, which led to extra dose administered (for 3rd dose vaccine). This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Information has been received from a medical assistant concerning an 18 month old male patient who "about two months ago", in approximately January 2010, was vaccinated with the first pediatric dose of VAQTA. The medical assistant reported that a recent hepatitis A titer performed to the patient was negative. It was unspecified if the patient sought medical attention. At the time of the report the patient had not recovered. Additional information has been requested.
Woke up in the middle of the night after the first dose with swollen feet, ankles, legs and tightness in chest.   Feet hurt to walk that morning, but that went away.  Reported it to my doctor.  She said to take some Tylenol and antihistamine.   A week later still felt like my calves were swollen and tightness/weakness feeling in my chest (like my heart muscle was weakened), and then more frequent heart palpitations--  so I went to Urgent care 1pm on Monday 8/30.  My EKG was showing abnormal (which it does often - due to Mitral valve prolapse), but they suggested I go to the Emergency room, so I went that afternoon.   I noticed my blood pressure was higher than normal at ER (which it's always the same), but the raised blood pressure coincided with chest pressure/pain.  ER recommended referral to Cardiology.   Since the first show, I've continued to have bouts of chest pressure/weakness feeling.  Also not sure if it was related, but had one morning after I went for a walk, I felt like I got really weak, felt faint, sweating-- kind of like low blood sugar.  Never really had that happen before.
Patient received a booster dose of Pfizer COVID-19 vaccine after previously completing his primary series with Moderna.  After vaccination, patient had a syncopal episode and fell to ground.  LOC lasted ~10-15 seconds.  Upon regaining consiousness, patient was positioned on his back with his legs raised.  Water was provided to patient.  PA at Health Center came and evaluated patient.  Vials: HR 77, BP 94/64, O2 98%.    Patient was then able to get into a seated position and was offered a soda.  Patient remained seated for 25 minutes and felt good enough to return to his room.
Client reported redness onto LDT with numerous 3-4 raised areas measuring totaling 40 mm-60 mm. No open areas noted.  No itching presented. Vital Signs:  9:25 AM-107/70;75,20-no c/o SOB. No c/o laryngospasm. A/O x3. Skin color-pink/skin-warm & dry. ARNP informed with recommendation of Benadryl IM; Dept Director/Dr. called at 10 AM with continued complaints of local reaction on LDT with Telephone Order for Benadryl 25 mg IM STAT-given to RDT.  Tolerated well with good effect.  Vital Signs:  @ 10:30 AM- 115/75; 84, 20- No SOB, No laryngospasm, Skin Color-pink; skin warm/dry.  11 AM:  Noted marked decrease edema and redness at injection site with area.  No open areas noted. 11:30 AM Injection site noted with slight pink colored with no redness noted.  Vital Signs-115/71; 88, 20. No SOB, No laryngospasm noted. Color-pink/skin-warm/dry. Emergency teaching provided to call EMS/911 for SOB or Emergency TX is required. Client able to repeat with good understanding.