chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported for any of them. The reporter informed that on unknown date, an unspecified number of patients were vaccinated with a dose of GARDASIL Intramuscular injection (dose number, route, anatomical location, batch/lot # and expiration date not reported). No adverse effects were reported. This is one of several reports coming from the same source. Additional information is not expected because neither the reporter nor the responsible physician wished to be contacted for further follow-up.
Fever began while at work.  After work temp was taken and remained @ 102.4 for four days.  Infection continued to the point that I was unable to move my arm.  After antibiotic I could move my arm only a little for a year.  The site of the vaccine continues to flare up and is currently sore, even after 2 years.
Redness at site of injection about 3 inches wide. Pt started noticing it today. No pain.
Information has been received from a physician concerning a patient female who in July 2008 was vaccinated with GARDASIL vaccine (yeast) 0.5ml IM. The physician reported that the patient fainted "last week" in July 2008 after receiving GARDASIL vaccine (yeast). The patient sought medical attention, she was seen in the physician office. ("AE occurred in the office"). There was no product quality complaint. No lab diagnostics were performed. On unspecified date the patient recovered. Additional information has been requested. This is one of several reports from the same source.
Client in clinic for second dose of Moderna vaccine. Moderna vaccine administered at 13:52. Client reports feeling like "her heart is clenching down" starting at 14:00. Client did not report symptoms to nurse until 14:15. 14:15-  Reports pain level 6 out of 10.  Denies shortness of breath. Breathing unlabored, and no diaphoresis noted.  Chest Pain protocol implemented. Vital signs within normal limits, aspirin administered, and oxygen applied via mask at 8 liters, 911 called. 14:30- Paramedics arrived. EKG obtained.  Per Paramedic report: EKG within normal limits, vital signs remain within normal limits.  Pain level decreased to 4 out of 10. Client refused to be transported to hospital by ambulance, she stated she would prefer her sister take her if she didn't start to feel better. Paramedics released client to care for self.  Client's sister to health department to pick her up. Sister stated she will take client to ER.
Patient received vaccine while seated and had no problems.  She stood up and walked several feet to the observation seating area and had a seat. A few minutes later she fainted and fell out of the chair onto the floor. We helped her up to a sitting position and gave her a bottle of water and an ice pack.  The right side of her forehead appeared red from apparent hit on the floor when she fainted.  We had her wait on the floor for about 30 minutes to ensure she remained conscious.  Patient reported an ache on her forehead at site of hit.  She was also sweating and reported feeling hot. Patient had a partner with her who agreed to escort her to an urgent care clinic in the same building as the pharmacy. Store manager in charge took the patient to the urgent care clinic by wheelchair to be examined.
Bexsero was given to patient instead of Menveo- no adverse reactions; no treatment needed
Severe abdominal pain in area of his kidney disease; diagnosed with urinary tract infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (Severe abdominal pain in area of his kidney disease) and URINARY TRACT INFECTION (diagnosed with urinary tract infection) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Polycystic kidney (polycystic kidney disease at stage three). Concomitant products included ALLOPURINOL, LOSARTAN, DILTIAZEM, ROSUVASTATIN and VITAMIN D3 for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced ABDOMINAL PAIN (Severe abdominal pain in area of his kidney disease) and URINARY TRACT INFECTION (diagnosed with urinary tract infection). On 14-Apr-2021, ABDOMINAL PAIN (Severe abdominal pain in area of his kidney disease) had resolved. At the time of the report, URINARY TRACT INFECTION (diagnosed with urinary tract infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Urinary tract infection: positive (Positive) diagnosed with urinary tract infection.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications provided was polycystic kidney disease meds.  Treatment medications provided was Intravenous antibiotics, Oral antibiotics, Pick line of antibiotics. Nephrologist advised stopping the oral antibiotic on 15 APR 2021 and everything appeared fine.  Patient undergone with the CT scan and Blood work.   This case was linked to MOD-2021-181828 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow up received. Patient demographics added. Concomitant products were added. Event outcome for abdominal pain updated. Inconclusive lab results were removed from patient tab and coded in iNarrative supplement.
I began experiencing the same symptoms I had after the second vaccine I had taken a while ago. Just general sick feeling that made me have to leave work early. While I was at home I began experiencing chest/back pains as well as pain in my left arm (which was strange as I got the vaccine in my right arm) when I was laying down that didn't go away unless I sat up.  I went to the Hospital last time for this event after my second vaccine but they didn't find anything worth concern.
Pt Admitted w/ AMS and COVID PNA on 3L O2, recieving remdesivir/dexamethasone
Hives and itching (whole body), burning sensation on bottoms of feet. On and off since 11/10/2021.
Grandfather stated child was complaining of her arm being sore later that after the vaccine, stated there was a knot, it was warm to the touch , and she was having stomach cramps
After vaccine administered the area around the injection was red and began itching. Still reporting itching 7 days later. Redness still only in injections site. No reports of shortness of breath or difficultly breathing.
Pt states her left arm started feeling itchy and then proceeded to have facial swelling and throat tightness.
24 hours after receiving the vaccine patient developed a quarter-size raised bump at the injection site; warm to touch, and red. Has not spread.
Information has been received from a woman in a physician's office concerning an 8 year old black female who on 04-AUG-1999 was vaccinated in the left arm with a first dose of Varivax (lot 628697/1838H). On 12-APR-2006 the patient experienced "<50". It was unknown if medical attention was sought. No additional information has been provided. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a patient who received FLUARIX QUADRIVALENT (batch number 77R93, expiry date 30th June 2018) and (batch number 34RE5, expiry date 30th June 2018). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, the dose was an unknown dose. On an unknown date, 5 min after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling, and injection site erythema were not recovered/not resolved. The reporter considered the injection site pain, injection site swelling and injection site erythema to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by Medical Assistant. The health care professional reported the patient had injection site reactions after receiving FLUARIX. The symptoms reported included pain, swelling, and redness the size of a half dollar. No patient information was available. This was 1 of 4 cases as reported by same reporter for same events.
2nd dose received 16 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received 16 days after the 1st dose) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received 16 days after the 1st dose). On 12-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received 16 days after the 1st dose) had resolved.            Concomitant product use was not provided by the reporter.  No treatment information was provided. Patient wanted to know where she can get the booster vaccine.
Mom started childs lip became swollen about 1-2 hours after receiving vaccination. 11/28/06 Received medical records from provider which reveal patient developed swollen lips approx 1 hour s/p vax along with emesis.  Developed a rash on outside of cheek & inside cheek swelling.  Referred for allergy testing & no further flu shots/new foods were to be given until testing completed.
1555 C/o burning ears and back of throat itching on phone. 1600 BENADRYL 25mg PO. 1604 C/o ears itching, difficulty swallowing, audible rhonchi with stethoscope. BP 180/110, HR-84, R-24 - Epinephrine 1:1000 0.3ml subcutaneous. 1642 swallowing without difficulty, no SOB, feels much better; given 25mg BENADRYL to take orally when arrives at home.  10/30/09:  Primary Care Records received for date of service 10/19/09. Assessment:  Called clinic to c/o burning ears and itching at back of throat.  Took 25 mg. Benadryl PO.  Denied allergy to eggs, feathers or chickens.  Did not recall any allergic reaction to any childhood vaccine.  Came back c/o of swallowing difficulties.  Nurse could hear rales without stethoscope.  PB elevated at 180/110.  Denied SOB.  Ears began to itch, no hives were noted. Epinepherine 1:1000 0.3 ml SQ was given.  Pt. stated short time later that swallowing had improved.  Given Benadryl 25-50 mg to take Q 4-6 hrs. PRN at home.  One additional Benadryl was taken when the patient arrived at home.  No itching or hives the next morning.
9/14 Tues. Wake up with mild aching pain in left thumb; spreads to fingers throughout the day; 9/15 Wed.  Aching mild pain in both hands; 9/16 Thurs. Pain in both hands, esp. fingers: feels as if toothpicks were stuck up through my fingers, very narrow, sharp and burning pain. Start taking ibuprofen for pain; 9/17 Fri. Pain has spread up to my wrists; my fingers become more painful. Pain begins in my toes; 9/18 Sat. Pain has spread up to my elbows, pain in places where it was already present becomes more acute. Pain in toes increases and spreads throughout my feet; 9/19 Sun. Pain increases and spreads up half-way up my upper arms and into my ankles. Overall pain increases even with an increased dosage of ibuprofen; 9/20 Mon. Pain spreads up to the shoulders and into my calves. At the tips of my fingers and toes pain increases significantly; 9/21 Tues. Pain spreads more into shoulders and just past my knees; pain is still burning and narrow, but it also begins to sort of vibrate and buzz more widely as well; 9/22 Wed. Pain continues. Hands and feet feel ?fuzzy?-- as though there is a tiny layer where the air is mixing with my skin and I don?t know what is skin and what is air. It?s not that my sense of touch is going away, but as though it?s coming from a long way away. The ?fuzziness? isn?t as sharp or intense as a pain, but in a way it is almost more uncomfortable or disturbing; 9/23 Thurs. Arm pain extends to shoulder blades. Appt w/Dr... blood tests conducted. Results returned ?nothing remarkable.? Ibuprofen no longer provides any pain relief; 9/24 Fri. I have realized that warmth makes the pain worse. Tried Tylenol-- has no affect on the pain; 9/25 Sat. Pain continues, plus all limbs have a slow, tired ache?in some sections the ache gets very severe; 9/26 Sun. Arm pain now extends through shoulder and into the front side of my neck; the leg pain now extends up through my buttocks. 9/27 Mon. Started taking Prednisone at 20mg daily per prescription. Pain extends into neck and under chin. 9/28 Tues. Pain extends into hips and lower back. Prednisone seems to help slightly; 9/29 Wed. Pain extends into side and front of chest; 9/30 Thur. Pain extends farther up the back; 10/1 Fri. Pain spreads into skull; 10/2 Sat. Pain encompasses entire chest. Overall pain increases; 10/3 Sun. Overall pain increases significantly. Pain encompasses entire back; 10/4 Mon. Pain extends into face; Overall, the pain is almost like a spiderweb: a lot of narrow, connected lines of intense, severe pain throughout my entire body. No place ever really stops hurting, but the pain is in so many places in that ?unless it?s really intense in a single place-- my brain just interprets it as general pain. It no longer bothers with location?it doesn?t really matter any more where it is because it?s all over in my limbs; 3-5 times a day I will feel really good?as though I?m getting better?but ~15 minutes later I?ll have a severe onset of pain in several areas.
Admission for aseptic meningitis 8 days after vaccine administration. Admitted 03/03/2005.
Vaccine given in office 1/17/08.  Seen in our office 1/30 with R thigh marked by indurated & erythematous circle 2cm.  Clear vesicle noted.  Several red papules on R wrist & forearm.  Being treated for LOM.
I had a bullseye rash about 7cm circular and 5 inches below the injection site that was red and hot. It was there for two days and went away. I had a 2.5cm  hot spot on my chin and the left cheek saw red and hot.
Initial report received from a consumer (patient) on 11 Nov 2010: This patient with unknown medical history had been vaccinated with flu shots in previous years. This year, the patient received FLUVIRIN (batch number 97841P1) on 01 Nov 2010. After vaccination, the patient's heartbeat became rapid and blood pressure elevated to a non-reported value. Exact event onset was not provided. The patient developed intermittent flush feeling in chest. When the patient woke up, blood vessel broken in right eye and blood shot was observed. The patient was recommended to take BENADRYL which helped her a bit; however the next day the symptoms continued. The patient visited to physician and an electrocardiogram (EKG) was performed which showed really rapid heartbeats. As measure, treatment with metoprolol was started. The patient's blood pressure had been elevated to 177/122 in past and remained elevated for a couple of days but now it was normal. Final outcome of the events was not reported.
Case number PHEH2012US009550 is an initial spontaneous report received from a health care professional on 04 May 2012 with a follow up information received on 21 May 2012. This report refers to an 11-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not specified. It was reported that on 04 May 2012, he received only the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: X10135B) intramuscularly on to unspecified site and did not receive the MenA lyophilized conjugate vaccine component. No adverse event was reported. He was scheduled for correct dose at next visit. Follow up information received on 21 May 2012: Patient demographics updated (age, date of birth, height and weight).
Right after the vaccine, I had a slight ache at the injection site - that lasted a couple of days at the most. June 12th, I had a diarrhea. The surgeon who took care of my rectum - his office ordered a stool sample. I picked it up and took it back the same day - positive result for C Difficile - oral solution of Vancomycin - 2.5 ml every 6 hours for 10 days. I see the surgeon for the post op check on July 13th and maybe he'll re-test at that time.
biceps and triceps area red and warm; upper biceps and triceps area red and warm; 2 lines going down in the arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (biceps and triceps area red and warm), ERYTHEMA (upper biceps and triceps area red and warm) and SKIN REACTION (2 lines going down in the arm) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-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 SKIN WARM (biceps and triceps area red and warm), ERYTHEMA (upper biceps and triceps area red and warm) and SKIN REACTION (2 lines going down in the arm). At the time of the report, SKIN WARM (biceps and triceps area red and warm), ERYTHEMA (upper biceps and triceps area red and warm) and SKIN REACTION (2 lines going down in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.
Soreness in left arm pit. Most likely swollen lymph node but the soreness is constant rather than just by touch.
PT. STARTED TO FEEL DIZZY 5 MIN. POST VACCINATION. PT. WAS GIVEN AMMONIA TO INHALE. AND B.P. WAS CHECKED WHICH SHOWED 107/51. PT. STATED SHE DID NOT HAVE ANY UNDERLYING CONDITIONS. PT. WAS FINE AFTER 10 MIN. AND LEFT FOR HOME STATING NO EMERGENCY IS REQUIRED.
Pain at injection site and shoulder; Fever; Sickness; Redness at injection site and shoulder; Swelling; This case was reported by a physician via call center representative and described the occurrence of fever in a 93-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever, sickness, injection site erythema, injection site swelling and injection site joint pain. On an unknown date, the outcome of the fever, sickness and injection site joint pain were resolved with sequelae and the outcome of the injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the fever, sickness, injection site erythema, injection site swelling and injection site joint pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced fever and sickness for the first two days after the administration of vaccine. The patient also experienced redness, swelling and pain at the injection site in the arm and shoulder. Redness and swelling last for 8 days and pain had gone at the time this report was performed The reporter consented to follow up. Batch number and expiration date were not provided since the vaccine was administered in a pharmacy and the physician was calling from his house.
pt recv vax & w/in 15-20min eye itching w/swelling;No SOB, wheezing, coughing noted;pt denies any discomfort other than eyes itching;BP 120/90, P 80 faint 930AM;
has Covid for the second time; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (has Covid for the second time) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 COVID-19 (has Covid for the second time). At the time of the report, COVID-19 (has Covid for the second time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Caller said her daughter has Covid for the second time and she does not know which vaccine she had and if it was Moderna or not.  No treatment information was provided.
Lack of efficacy- EE had a positive rapid COVID test on 18Nov with symptoms beginning 15Nov; had become symptomatic on 15Nov; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Mar2021 (Lot number: EL3247) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Pfizer COVID19 vaccine Dose 1 ,  lot number: EL3247,  Intramuscular, Vaccine location: Left arm), administration date: 11Feb2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Nov2021, outcome "unknown", described as "Lack of efficacy- EE had a positive rapid COVID test on 18Nov with symptoms beginning 15Nov"; EXPOSURE TO SARS-COV-2 (medically significant) with onset 13Nov2021, outcome "unknown", described as "COVID19 exposure on 13Nov2021"; COVID-19 (medically significant) with onset 15Nov2021, outcome "unknown", described as "had become symptomatic on 15Nov". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, exposure to sars-cov-2, covid-19.  Clinical course: On 18Nov2021 that she tested CV19 positive on 18Nov2021 by rapid test, had become symptomatic on 15Nov, and had close contact on 13Nov2021 to someone who later tested positive for COVID19. It was unknown if patient had covid prior to vaccination and unknown if received any other vaccine in four weeks   No follow-up attempts are possible; No further information is expected.
The medical history reportedly included "chronic migraines" treated with Surmontil and Neurontin. The pt stated that she did not have gout, psoriasis, Crohn's disease or a previous history of Lyme disease. There reportedly was not family history of rheumatoid arthritis or lupus. On 1/9/02, the pt received her 1st injection of Lymerix. On injection, she reportedly experienced injection site soreness that resolved after an unspecified period of time. On 2/9/02, the pt received her 2nd injection of Lymerix. She reported that on 2/21/02, 12 days post vax, she experienced "pain and achiness in all muscles and joints of the body including hands and toes", headache, "extreme" fatigue and chills. These persisted as of 2/27/02 and the pt had an appointment to be evaluated by her physician. The adverse events "joint pain" and "headache" do not meat ICH serious criteria.
Left arm swollen, red, sore, shivers, muscle soreness, lethargic
Nausea, headache, armpit pain, muscle pain, injection site pain, tiredness