chrisvoncsefalvay/vaers-outcomes huggingface dataset:
24 HOURS LATER SPOT RAISED AND EXTREMELY ITCHY; FELT ITCHY; RASH LIKE WELT AT THE INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (FELT ITCHY), VACCINATION SITE RASH (RASH LIKE WELT AT THE INJECTION SITE) and VACCINATION SITE URTICARIA (24 HOURS LATER SPOT RAISED AND EXTREMELY ITCHY) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Adverse event (No medical information provided).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (FELT ITCHY) and VACCINATION SITE RASH (RASH LIKE WELT AT THE INJECTION SITE). On 20-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (24 HOURS LATER SPOT RAISED AND EXTREMELY ITCHY). At the time of the report, VACCINATION SITE PRURITUS (FELT ITCHY), VACCINATION SITE RASH (RASH LIKE WELT AT THE INJECTION SITE) and VACCINATION SITE URTICARIA (24 HOURS LATER SPOT RAISED AND EXTREMELY ITCHY) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications were reported no treatment drugs were reported   Reporter did not allow further contact
Developed pneumococcal sepsis 2 days later; This is a spontaneous report from a contactable Physician via Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , via an unspecified route of administration on an unspecified date at single dose for immunisation .  The patient medical history  and concomitant medications were not reported.  The patient developed pneumococcal sepsis on an unspecified date two days after receiving vaccination  with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information current currently available, no LOE with PREVNAR 13 is clearly implied for the onset of Pneumococcal sepsis occurred two days after receiving vaccination, which most likely represents an intercurrent severe bacterial infection. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
I just tested positive for Covid for the 1st time 10 days ago; I just tested positive for Covid for the 1st time 10 days ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Granulomatosis with polyangiitis" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing), notes: Being a high risk person with an autoimmune disease; "immunocompromised" (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 Nov2022, outcome "unknown" and all described as "I just tested positive for Covid for the 1st time 10 days ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Patient just tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient just tested positive for COVID for the 1st time 10 days ago. Patient had all COVID vaccines. Being a high risk person with an autoimmune disease patient got on Paxlovid that day. The next day patient felt much better and the rest of the time patient was on Paxlovid patient felt better than patient do when patient get a mild cold. Now 5 days after being off of it, patient feel horrible. Patient thought Paxlovid dosing should be extended for immunocompromised people past 5 days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
developed worsening shortness of breath with a dry cough shortly after vax which brought him to the ER.  Found to have PNA and pleural effusion.
This case was reported by a consumer via call center representative and described the occurrence of polymyalgia rheumatica in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, 91 days after receiving SHINGRIX, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant). On an unknown date, the outcome of the polymyalgia rheumatica was unknown. It was unknown if the reporter considered the polymyalgia rheumatica to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The reporter's physician indicated that, he had other patients that were diagnosed with polymyalgia rheumatica. The reporter was going to talk to her rheumatologist and get the names of the other patients that were diagnosed with polymyalgia rheumatica three months after vaccination. The reporter was considering filing a lawsuit. This case has been linked with case US2019065952, reported by the same reporter.
I was lightheaded with a cough, exhaustion and congestion. On the 24th I started feeling ill and tested positive on the 26th and negative on the 28th and wasn't feeling better. I went to my doctor and he said I had a secondary respiratory infection and I was given antibiotics.
Immediate allergic reaction to first dose of vaccine, tongue swelled, could not swallow, face hugely flushed, unusual allergic reaction compared to past. Was a drive-thru clinic in early January, and there were no medical staff present, no epi pen administered. 8 minutes later, the reaction began to pass, waited for another hour and the symptoms subsided somewhat. 3-4 swelling in neck, fatigue, issues affecting voice box, etc. Slowly has dissipated over time. Doctor recommended not to get the second vaccine, due to allergic reaction.
4 hrs p/vax exp high pitched cont crying for 3 hrs; no sz;
Headache within about 50 minutes of receiving shot; intense fatigue by six hours later. Day after shot, awoke with every joint in my body swollen. (literally - all).  Entire week following, experienced excessive fatigue. Never experienced any muscle soreness, not even at injection site.
Moderna COVID-19 Vaccine EUA: After injection I had no symptoms until approx 4 hours later when I felt anxious, agitated and extremely irritable w/ very short temper. About an hour later while watching TV, a hot flash/flush came over my head and upper torso. I noticed bright red checks and nose which resolved within a couple hours (without any intervention). Temp was elevated per touch, and clammy. Blood pressure was elevated for several days 160-180s/86-100. A small scar on my finger from cyst removal 7 wks prior became inflamed and red w/ burning/tingling for 3 days.   Anticipated SE did included head ache, sore arm, fatigue and sleepiness for 2.5 days. (previous vaccines only resulted in sore arm--all other SE above (esp becoming possessed with fury), were new experiences.
felt completely "zapped; Slept all night; started feeling weak; fever; full body muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt completely "zapped), HYPERSOMNIA (Slept all night), ASTHENIA (started feeling weak), PYREXIA (fever) and MYALGIA (full body muscle pain) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced FEELING ABNORMAL (felt completely "zapped), HYPERSOMNIA (Slept all night), ASTHENIA (started feeling weak), PYREXIA (fever) and MYALGIA (full body muscle pain). At the time of the report, FEELING ABNORMAL (felt completely "zapped), HYPERSOMNIA (Slept all night), ASTHENIA (started feeling weak), PYREXIA (fever) and MYALGIA (full body muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Ringing in ears and hearing loss in left ear, Some hearing has returned but ringing has remained and is much worse than prior to the vaccine.  Right ear ringing has reduced substantially but is worse than prior to the vaccine.
Returned to clinic after about 1 hour with right facial swelling. Edema noted on face, near right ear. No SOB noted. Respirations even and unlabored. No swelling noted of airways. Instructed to take Benadryl by mouth and go to ER.
per patient: left upper arm at vaccine site was swelling and rash begun the next day. Rash and swelling still last till now, itching and warm when touch. All symptoms get better now. Other than that patient is ok.  per patient: she will inform her primary care doctor.  Advise patient seek medical attention if needed.
fever; chills; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and CHILLS (chills) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 31-May-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.   Reporter did not allow further contact
nose bleeds; fatigue; chills; achiness; A spontaneous report was received from a consumer concerning a 72-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, achiness, nose bleeds and fatigue.  The patient's medical history was not provided by the reporter. No concomitant medications were not reported.   On 24 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 25 Feb 2021, the patient experienced chills and achiness.  On 28 Feb 2021, the patient experienced nose bleeds and fatigue.  Lab details was not provided.  Treatment for the events was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, chills, achiness was recovered. The outcome of the events, nose bleeds and fatigue were unknown.
Pfizer on 3/19 and 4/9. Positive on 9/20
Patient is believed to have extensive site reaction at time of administration no significant reaction slight pink area after 15 minutes. Patient states it became red & stretched 4" x 1" feels like persistent bee sting/sore after 3 days. However she feels it may go down.
This prospective pregnancy case was reported by a physician and a healthcare professional and described the occurrence of incorrect storage of drug in a 30-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) during pregnancy. Concurrent medical conditions included sulfa allergy. On 15 September 2011 the subject received a dose of FLULAVAL (.5 ml, unknown route, right arm) that had been left out of refrigeration for 7 days, and experienced incorrect storage of drug and vaccine exposure during pregnancy. Gestation age at the time of vaccination was unspecified. Date of last menstrual period and estimated date of delivery were not reported. 26 September 2012 - No further information provided; patient lost to follow-up. Follow-up information was received on 10 October 2012 via healthcare professional who reported the subject received a pneumococcal vaccine on an unspecified date. The subject's last menstrual period was on 02 April 2011 and estimated date of delivery was 07 January 2012. The pregnancy was by normal conception and consisted of one fetus. On 17 December 2011, at 37 weeks gestation age, the subject gave birth to a male live infant. The infant was delivered by normal vaginal delivery, weight 2.73 kilograms; length and Apgar score were not provided. The healthcare professional considered the events of vaccine exposure during pregnancy and incorrect storage of drug to jeopardize the subject or required intervention.
Swelling, redness, soreness at injection site and radiating down arm about 5 inches. Advised pt. to ice area every hour for 10-15 minutes and take TYLENOL as needed.
Mother called the day of the vaccines stating that she was fussy and would not stand on legs. Reassured this can be normal after vaccines no redness, no lumps or bumps. Okay to given MOTRIN. Mother call this morning stating child has fever of 103.1 and still won't stand on legs. Denies any redness, swelling or bumps at injection site. Asked her to MOTRIN and I would call her back. Called back 1 hr later fever down to 99.5. Still won't walk. Asked her to try giving her a warm bath to get her to play. Will call back to see how she is doing. Called mother back. Child is now walking around and playing.
Received vaccines at 3:30pm, around 5:30pm experienced fever and malaise, by 7pm extremely tired. Approximately 1am vomited, shivering/chills and fever. During the following day vomited again, chills & shaking occurred again, fever (102.4). The next day (3 days after receiving vaccine) pain in left arm, chills, fever. Mother gave patient alternating tylenol and advil with some relief.
Client had a bad taste in mouth and became nauseated, vomited; severe lower back pain in less than 2 minutes following the shot. The doctor examined her medication were administered.
This medically confirmed spontaneous report (initial receipt 11-Oct-2012) concerns a 3 year old patient. On 11-Oct-2012, the patient was inadvertently administered AFLURIA (batch P58807) via intramuscular route at a dose of 0.5 ml. No adverse effect was reported. The event outcome was unknown.
The LVN was giving Pentacel, she gave the DTaP, and Polio antigens with the ActHib component. The child received the correct antigens, but they were mixed incorrectly.
Pt. arrived for second Pfizer vaccine on day 13 after first dose requesting an exception for travel plans. Medical Site supervisor is informed and placed call to Dr. (Name) to confirm dosing schedule for Pfizer. After updated Dr. (Name) approves vaccination with education of pt. on risks of early vaccination. immunization registry at checkout discovers pt. had full Moderna series in late Jan/early Feb. Dr. (Name) is notified. Pt. left clinic before education could be given
hypotonia;sinus tachycardia-heart rate 200 BPM;decreased strength;pt was improved when re-evaluated 6/5/99;
On 1/21/21 developed all over the body red rash. No swelling, no itching.  On 1/22/21 it was gone when she woke up.
Patient was vaccinated at 12:25. At 12:32, Patient states that he " feels numbness and tingling on right arm", where patient got vaccinated. RN assessed patient , vitals : BP 142/86, HR 69, Spo2 99%. Pulses noted on both arms. Hearts sounds present. No respiratory distress.  Patient states no other symptoms. Patient waited additional 15 minutes. RN reassessed and patient states that numbness and tingling went away fully. Vitals: BP 130/85, HR 60, Spo2 98%, Patient cleared by clinical staff.
Severe abdominal pain, vomiting, diarrhea, muscle pain, headache, fever
1st dose of the Pzifer vaccine was administer 5/16/21 in the left arm.  Since then I still have pain in the site of the vaccine.  I might think that the reaction is more to how the vaccine as administer that the vaccine itself.  Despite applying ice for many weeks, I still experience discomfort at the site of the vaccine and minor burning.
This case is for 58 patients and link with #2013SA106326, 2013SA106345, 2013SA106341 with same reporter, same product. Initial report received from a healthcare professional on 18 October 2013. 58 patients (demographical details was not reported), whose medical history and concomitant medications were unknown, had received intradermal dose of FLUZONE ID (batch number: UT4720AA, anatomical site of administration was not reported) on 01-Oct-2013. It was reported that all 58 patients had site reactions such as wheal and urticaria at sites with warmth at the site on an unspecified date. Corrective treatment and lab details were not reported. The outcome was not reported. Documents held by sender: none.
Information has been received from a certified medical assistant (CMA) referring to multiple unspecified patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored (Merck) PROQUAD (lot#, expiration date, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
About 3 months after receiving my vaccine, I thought I had a COVID-19 exposure, but everyone tested negative as well as myself. However, I couldn't seem to shake my symptoms. I was wheezing at night and taking ROBITUSSIN repeatedly, but nothing helped. I had shortness of breath, hoarse throat and voice, sinus issues/mucus congestion, asthma symptoms, and coughing. For the longest, I thought I had pneumonia. The coughing seemed to subside, but the sickness wouldn't go away. I went to the doctor, and they think I'm not breathing deeply enough. They performed a chest x-ray on me on 03/07/2023. I was given some breathing exercises to practice; I was recommended to see an ENT doctor in April and a breathing test scheduled this week to test my breathing function.
Started Tues evening 3/13/2018 to Wednesday all day. Side effect was mostly on Wednesday all day. Could barely walk, extreme dizziness, couldn't turn head, hurts to sit. Trouble keeping balance.
Nurse administered 0.5ML dose instead of the intended 0.3ML dose.  No side effects seen at the time of administration.  RN indicates it was a slip in her mind since she previously worked at a Moderna clinic.
I received a call from this patients' spouse.  He got the vaccine at 5pm and left the store shortly thereafter.  While driving home, he felt faint then his body became numb all over and then he blacked out.  He woke up in a car accident. He was taken to the hospital and is OK.
Patient presented to the pharmacy today 06/26/21 with a rash that started about 4 days after the vaccine was administered which was on 06/08/21. He also says that he has some radiating pain that wakes him up at night on the same arm and his arm feels hot. I recommended diphenhydramine at night to help him with the rash.
Nausea-24 hours (no vomiting). Muscle weakness, particularly lower extremities.
Multiple arthralgias but severe plantar fascitis, right sided sacroileitis, bilat lumbar facet capsulitis, multiple bilat hand flexor tendonopathies and trigger fingers.  Arthralgias resolved and plantar fascitits, sacroileitis and facet capsulitis nearly/completly resolved.  Multiple nodules in hand flexor tendons bilat that will require surgical release due to disability
No adverse events until I took a 400mg tablet of Guaifenesin @ 6:00AM on the 7th followed by another tablet 5 hours later at 11:00AM. Didn't notice anything until getting ready for bed. There was a raised red welt area about 2 inches wide and 3 inches long on my left arm, just below where I received the injection. Didn't itch or even know it was there before I saw it.  Today it has a more pronounced profile, no wider or longer, but raised edges or more puffy. Still no other indication it is there. I will moniter and let them know when I get my second dose.
Pt. c/o symptoms of fatigue and dizziness on 3/2. On 3/3 pt. presents to ER, afebrile, c/o fatigue, feeling of being lightheaded, reports syncope and falling x's 2. Pt. according to MD documentation was in good health. Denies any recent illness. Pt. was found to be bradycardic, sick sinus syndrome, r/o MI. Pt. was transferred to higher level of care hospital on 3/3. Pt. had emergency pacemaker insertion. She became hypotensive and hypoxic post-op and was found to in lactic acidosis. Pt. expired on 3/3/21.
on 2/28/2021 woke with sore arm, chills,.shortness of breathe, mild body aches all were gone by2/30/2021. on 3/07/2021 experience shortness of breathe, chills and a lot of stomach and intestinal gas  also hard a rash on left shin area these were gone by 3/08/2021 except for rash on shin which is slowly going away.
Headache, Myalgia, Arthralgia, NauseaVomiting, Fatigue Narrative:
Red, hot, and splotchy area appeared on the left side of my neck 12 days after receiving Moderna booster. Rash started at about 7:30 pm on 12/02/2021 and continued to spread to my scalp and other areas of my neck. By 7 am on 12/03/2021, the rash had started to spread to other areas of my body including legs, feet, torso, back, hands, face. Rash continued to get worse throughout the next several days, very reactive to touch and heat. Very itchy, hot, raised, red, hives in splotches and linear pattern. Improved immediately after starting oral steroid. Still present over one month later but less severe.
Hives, itching since evening of injection "eyes bothering", face tingly. Patient self treated with BENADRYL, will continue BENADRYL.
This spontaneous report was received from a physician concerning a patient of unknown age and gender. On 05-AUG-2011, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly and subsequently was vaccinated with the second dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly on 01-OCT-2013. No concomitant therapy was reported. No adverse effect was reported. This is one of the two reports from the same source. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient's parent). A 24-month-old male patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, reported as recently, the patient had lavages taken during a bronchoscopy and streptococcus was identified in his upper airways. The pulmonologist then measured his serum titers to the streptococcus serotypes in pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) and he had low/no reactivity to serotypes 3, 5, 19 (19F), 26 (6B), 56 (18C), and 57 (19A). The outcome of the events was unknown. The information on the lot/batch number has been requested.