chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tdap given in L deltoid on 3/20/2023, next day localized swelling & redness wheal about 3.5 inches, per dad. On 3/22/23, sat pt. with diffuse Redness about 3inx4.5in with induration in the center, mild warm to touch, no tenderness to touch, fill ROM BUE without pain; no signs of body rash normal facial swelling.
Developed chicken pox. BACTROBAN to affected area by topical route 3 x day for 7 days.
Sinus infection; legs cramping; body aches; muscles burn; high fever 103.3 F.; severe headache; chills; felt really sick; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), PYREXIA (high fever 103.3 F.) and HEADACHE (severe headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical histiory).    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced SINUSITIS (Sinus infection), PYREXIA (high fever 103.3 F.) and HEADACHE (severe headache). At the time of the report, SINUSITIS (Sinus infection), PYREXIA (high fever 103.3 F.) and HEADACHE (severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 103.3 (High) 103.3 F. On 02-Mar-2021, Influenza virus test: negative (Negative) negative. On 02-Mar-2021, SARS-CoV-2 test: negative (Negative) negative.         Very limited information regarding the events has been provided at this time. The events were consistent with infectious process. Company assessed the events to be unlikely related to company product.
At 12:28 p.m. on Saturday, April 10, my blood oxygen went down to 87%. I felt cold, had chills, and was shivering. I felt weak and felt malaise when i stood up. I was monitoring my blood oxygen and temperature. Blood oxygen improved but I still felt malaise, weakness. I took one 600 mg ibuprofen at 2:40 p.m. At around 3:43 p.m. my blood oxygen was 98% and i felt better finally. Subsequently, I took 2 (200 MG) Advils at 9:50 p.m. before going to sleep. At 2:00 p.m. on Sunday, April 11, I got up to get my salad out of the fridge and I started feeling malaise. My heart rate went up, I was breathing shallow. I drank 2 Advils (400 MG). I took 1 more ibuprofen at 3:30 p.m. I felt bad until before going to sleep. Before going to sleep, I drank chamomile tea to help me breathe better and took 3 Advils. At around 8:00 p.m. on Monday, April 12, I started to experience shallow breathing. I made myself chamomile tea and drank two cups but it didn't seem to help shallow breathing. I then made myself a tea with ginger, turmeric, cayenne pepper, black pepper, lemon peel, lemon juice, coconut oil and honey. I drank it around 11:25 p.m. I was up until after 12 a.m. until finally I felt I could breathe better and went to sleep.
rash with blister; severe acid reflux; muscle weakness; headache; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2022, the patient received the 1st dose of Shingrix. In September 2022, less than a day after receiving Shingrix, the patient experienced muscle weakness, headache, blistery rash and esophageal acid reflux. On an unknown date, the outcome of the muscle weakness, headache and blistery rash were recovered/resolved and the outcome of the esophageal acid reflux was not recovered/not resolved.   It was unknown if the reporter considered the muscle weakness, headache, blistery rash and esophageal acid reflux to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-NOV-2022 Reporter's comment: The reporter was calling on behalf of the patient, her aunt. The patient received dose of Shingrix vaccine about 2 months ago from the date of reporting in left arm and experienced side effects within 24 hours like muscle weakness and headache, that lasted about 1 week.  The patient also experienced rash with blister (not sure exact location) that lasted 2-3 weeks and severe acid reflux which had not resolved. The reporter did not consent to follow-up.
arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm sore).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVILMED) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Immediately after administration of the Pfizer vaccine, patient complained of rapid heart rate, pulse was rapid.  Skin was warm and dry.  Nurse initiated after five minutes patient report improved breathing, BP 150/100.  Nurse team recommended continued observation and if condition changes, report to ER.  Patient elected to remain at the Covid Clinic.  After twenty minutes of continued observation, patient elected to go to ER for assessment and continued observation.  Patient transported to ER by RN via wheel chair and report given to Triage Nurse.
Per client's mother, client experience itchiness at injection site and red bumps. Client's mother reports she is treating with over-the-counter BENADRYL and cold-compress applied to injection site.
Pt presented in Septic shock w/ DIC around MN on day of receiving 1st set of immun; Pt blood grew H. Flu from blood culture;
Patient experienced confusion, memory loss, and had no sense of direction. She was driving with her husband and couldn't recall where she was going or why. Her husband instructed her to pull over and then took her to the ER. At the hospital, she began to regain awareness and memory. As of now, she still does not recall the time period when she was driving. Patient states that she has a good memory and is always alert. Hospital ran tests for stroke but nothing medically wrong was found. On Monday 12/17/12, the patient called me to ask about ingredients in the Fluzone she received on Saturday. She believes it was an allergic reaction to the vaccination. The hospital provided no treatment as the symptoms had resolved on their own. The hospital did not call regarding the vaccination.
severe pain at injection site, 2 days post injection - rash developed on chest and neck and lasted for ~2 weeks. Also experienced lymph node pain under both arms
Developed mild vesicular rash, presumed mild varicella with lymphadenopathy of the posterior auricular glands.
Left arm vesicles, papules, anted  (aggregated) lesions with pruritus, erythema and edema of arm. Also severe pain at arm Tx: Allegra 60mg BID/ Bactroban/ Diprolene
While waiting the 15 minutes after his first dose of Pfizer (about 5 minutes after the injection), patient let me know he was feeling faint, sweaty, like he passed out. I came out to check on him and he was extremely pale and sweaty. I got him some water and a cold, wet paper towel for the back of his neck. When I asked if he had eaten breakfast, he said had not eaten. I gave him a sucker to get some sugar in his bloodstream.
This spontaneous report was received from a certified medical assistant concerning to an unspecified number of patients of unknown age and gender. Information regarding the patient's medical history, concurrent conditions or concomitant medication was not provided. Between 02-JUL-2015 and 04-AUG-2014, the patients were vaccinated with M-M-R II lot # K002816 with expiration date of: 25-FEB-2016 and lot K006141 with expiration date of: 29-APR-2016 (strength, dose and route of administration were unknown). That was improperly stored at a temperature of 32F during 6 hours. No adverse events or product quality complaints were reported. Additional information has been requested.
Booster shot on 11/08/2021. About 11/15/2021 started chest pain and shortness of breath. Saw my primary doctor on 11/19/2021. She did EKG etc.. Provisionally diagnosed Pericarditis and sent me to the emergency room where I was admitted 11/19/2021, treated, and discharged 11/22/2021.  I had a reoccurrence of pain and sob on 12/03/2021, went to ER, admitted to local Hospital on 12/03/2021. Treated and discharged on 12/07/2021. Diagnosed with Pericarditis.  Am presently being treated with medication.
Pt. reports feeling ill in the evening of receiving the immunization - temp. 102.5. Next day arm was painful, red, swollen.  Seen by MD with dx. of cellulitis. Tx with Augmentin 875mg. BID X 10 days.  Both shots given in same arm per patient request.
My symptoms after the Covid Vaccine were similar to the Multisystem Inflammatory Syndrome affecting my eyes, heart, and colon. Within 18-20 minutes of receiving the vaccine I had severe shooting pains down my arm from the injection site, within a few hours, chest pain with excessive irregular heart arrhythmias, deep pains shooting down the leg. The next morning, chills, fever at midday, eyes inflamed and hurting, and continued heart irregular beats... it felt like my heart was doing flips, but eye pain was the worst. Extreme fatigue and body aches and high fever for a few days. Had to see an eye doctor and make emergency Eye Foundation hospital visit due to severe pain and lesions in my eye. After getting better from the eye, I developed Colitis....ER visit for severe epigastric pain. I was put on Vancomycin for that. Within 48 hours of the antibiotics, my heart finally stopped having all the constant arrhythmias. My eyes, colon, and heart were affected greatly by the vaccine. I can't risk losing my vision. Even though my Ophthalmologist, Primary Care Physician, Cardiologist, and Gastroenterologist suggested going ahead with the 2nd vaccine and taking precautions, I'm too terrified to take another vaccine. I promised God that if he would let me live through all of that, I wouldn't take another one, so I have not. Not only that I can't afford this to happen again. This cost me a fortune!
Rash - Information has been received from a company representative concerning a 12 month old male patient who on 22 May 2000 was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Conmitant vaccination that same day included one dose of varicella virus vaccine live (KSD).  On 26 May 2000, the physician was informed that the patient developed red maculopapular eruptions scattered over his body.  Unspecified medical attention was sought.  Follow up information from the health care facility indicated that there were no other adverse reaction
05/09/2022 I had an episode tachycardia, I started to feel lightheaded. I checked my pulse. I had a rate of 205. I was not discernible, I started to drive myself to the clinic, it self-converted. The doctors did an EKG, and set me up the following Wednesday, 05/11 to see a cardiologist. I had an episode of syncope on 05/11. I did a self transferred me to the ER. And they did the full work up on me in the full blood work, chest CAT scan, EKG everything was clear. No heart attack, no brain issues. There was no reason I should of had the tachycardia. I was in the ER for 12 hours. They are going to monitor my heart for 48 hours on 6/2 thru 6/3 heart monitor. And on 6/7 I will have a cardiogram. I am still getting a few bouts of headaches. I have not had any of the symptoms of the tachycardia or the syncope. I have not had that again.
Shaking; Joints hurt; I feel like I have flu; Chills; Fever; I have been taking Tylenol and I have slept almost whole day and I feel better now but I still really feel bad; I am too tired; I still really feel bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 30Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series completed, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "Shaking"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joints hurt"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "I feel like I have flu"; CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; SOMNOLENCE (non-serious), outcome "unknown", described as "I have been taking Tylenol and I have slept almost whole day and I feel better now but I still really feel bad; I am too tired"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I still really feel bad". Therapeutic measures were taken as a result of chills, pyrexia.  Additional information: It was reported that concern, consumer stated, "I had the 2nd Booster (Pfizer COVID-19 Vaccine) yesterday afternoon and I woke up 3 am this morning I was shaking, my joints hurt, I feel like I have flu, I have slept almost whole day. So, is that abnormal reaction?". Vaccine name: Pfizer COVID-19 Vaccine. When paraphrased the concern, consumer stated, "Yes." Consumer was informed about the role of Pfizer Drug Safety. Consumer was informed about Pfizer Medical Information Department for the concern. In response consumer stated, "Ok, I have been taking Tylenol for chills and fever and I almost slept whole day. I have been taking Tylenol (suspect captured conservatively) for the chills and fever and I have slept almost whole day and I feel better now but I still really feel bad." In response to further probing consumer stated, "Transfer me please." In response to file safety report consumer stated, "I think so, that's fine, I just want to know if this is a normal reaction. My granddaughter had no reaction, a friend of mine had no reaction but I guess I am the one (experienced event)." When offered Pfizer Medical Information Department contact#, consumer stated, "No, I am too tired to look for pencil and paper, please transfer me." Call transfer to Pfizer Medical Information Department was initiated, however it was unsuccessful. Consumer was not willing to proceed the call. Hence further probing could not be done. Limited information was available over the call and appropriate response could not be provided. Reason for no lot number: of COVID-19 Vaccine: Caller unwilling to complete the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Child was found apneic in his crib.  EMS was contacted.  Mother performed CPR.  Child was pulseless when EMS arrived.  Upon arrival to local hospital, child was asystolic with no response to chemical resuscitation.
12 hours of getting vaccine pt had chills, fever (102), aches. Very sore arm with redness 5 weeks.
DAPTACEL (RT) PEDVAX (LT) given at 1430. Well tolerated. Arrived home - baby normal, went to sleep, woke up at 1800, cried 2 hrs. RT redness noted, went to sleep at 2030. Woke 1230 fussy, small feeds til 0500 - emesis, refused feed. Slept til 1000. Cont. to be fussy. Called physician during the night.
9-10-15 presented with small bumps on legs with itching. Dx with folliculitis and tx with hydroxyzine, betamethasone valerate 0.1% cream and clindamycin phosphate 1% cream from Dr. 9-14-15 presents with worsening rash now small erythematous papules on trunk and extremities morbilliform on upper legs/hips. Tx with ZYRTEC 10mg, ZANTAC 150mg, prednisone 20mg.
dizziness; extreme itchy skin; headache; fatigue; This is a spontaneous report from a contactable other-healthcare professional reported for herself. A 48-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL9262), via an unspecified route in the left arm on 19Jan2021 at 14:30 (age at vaccination: 48-year-old), as a single dose for covid-19 immunization. Medical history included asthma and Known allergies: Sulfa Drugs. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 19Jan2021 at 15:30, after first shot patient experienced dizziness and extreme itchy skin 1 hour after shot for approx. 2 hours before it ended, then headache and fatigue for 1-2 days. However, after 48 hours all effects from the 1st shot were gone. Patient did not receive any treatment for the events. The clinical outcome of the events was recovered in Jan2021.  Follow-up attempts completed. No further information expected.
Slight itching around the site (L deltoid area) followed by pain and stiffness in Left shoulder and upper arm. I took ASA gr. X at $:30 PM.  At 5:30 PM I noted slight pain reduction, but swelling and r3eddness.  The area of swelling and redness increased throughout the evening. I put ice on the area at 9:00 PM with some relief; took ASA gr. X at 11:30 PM with some pain relief.  The area of redness and swelling had increased and become harder.  I also put a warm compress on the area. 11/11/2015 @ 7:30 AM I awoke and found the area of swelling and redness had increased further, but the pain was much decreased.  I took ASA gr.X at 8:00 AM with some relief of discomfort, but at 1:00 PM, the area of swelling and redness had increased more. I iced the area again with relief of discomfort, but no reduction in swelling or redness.  At this time 4:30 PM, the area of involvement is ~ 6.5 x 4" over the outer aspect and biceps area of my left arm.  I have no itching, minimal pain (except for stiffness due to swelling), and no other symptoms.
spasms around the trachea & back of the throat; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Product: PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration on Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced spasms around the trachea & back of the throat. Caller asking if symptoms have been reported. The outcome of the event was unknown.  Information about the lot/batch number has been requested.
Rash on his palm and it was that spreading over 2 weeks to the hand and to the feet, also rash on the tongue; This is a spontaneous report from a contactable physician. A 15-years-old male patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: was not reported) via an unspecified route of administration on 27May2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had not any other history and products. It was reported that, patient had the reaction to the COVID-19 vaccine. Patient had vaccine on 27May2021 and next day on 28May2021 he developed rash on his palm and it was that spreading over 2 weeks to the hand and to the feet, also rash on the tongue. So, the rashes were for 2 weeks. The department of health told the physician that not to give the second dose of vaccine to the patient. Reporter seriousness for Rash on his palm and it was that spreading over 2 weeks to the hand and to the feet and rash on the tongue was unspecified. Therapeutic measures were taken as a result of adverse events as patient had received treatment with Benadryl, Prednisone, Cefalexin. Cefalexin was 500 mg 2 times a day for 7 days, Benadryl 25 mg 2 times a day prm (further not clarified) and Prednisone 60mg once a day for 3 days. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of rash cannot be excluded. 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.
MOTHER CALLED AFTER HOURS SERVICE ON 5-4-07--STATES INFANT CONSTANLY CRYING HALF OF DAY AND LOOKS VERY SICK TO HER. SHE WAS ADVISED TO TAKE THE INFANT TO THE ED FOR EVALUATION.  MOTHER STATES ED ADVISED INFANT IS MOST LIKELY HAVING A REACTION TO THE VACCINES.
Less than 24 hours after child developed a hard, red swollen area around injection site, several blisters were present. Parents felt child had fever, no recorded temp but gave TYLENOL. Resolved by 8/3/15.
Injection site discoloration; The area became itchy; Large red area the size of a grapefruit presented at the injection site; hot to touch; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd May 2019, the patient received the 1st dose of Shingrix. On 4th May 2019, 2 days after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. In May 2019, the patient experienced injection site discoloration and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site itching were recovered/resolved and the outcome of the injection site discoloration was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site discoloration and injection site itching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in her left arm. Two days after receiving the 1st dose, the patient had a large red area the size of a grapefruit at the injection site.  It was hot to touch.   It resolved after 8 days but there was still some slight discoloration in the area.  Two weeks following the injection, the area became itchy and it lasted for 4 or 5 days.   The patient did not consent to follow up. The patient received 2nd dose and had some adverse events, refer case US2019157518.
19MAR93 1020AM pt c/o inc temp, pain on lt shoulder, h/a, & pain in both legs; no relief of temp w/APAP; MD prescribed DPH;
Patient given 0.5 ml of 3rd dose instead of 0.25 ml booster dose. No adverse effects noted. No interventions needed.
After having minimal soreness, one week after the injection, on 1/23 the injection area started to itch and is red and the area is still swollen. Is this ok.