chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse concerning her 58 year old physician husband with no drug reactions or allergies and a history of positive tuberculosis skin test in 1979 who on 13-AUG-2012 in the morning, was vaccinated IM in the left deltoid with 0.5 ml dose of PNEUMOVAX 23 (lot # 1947AA, exp 20-OCT-2012). No concomitant medications were reported. A few hours later, the site of the injection was sore. By 7:30 PM that evening, the patient was pale, weak, felt feverish, had chills, and the injection site had a tennis ball-sized area of severe soreness, redness, swelling and was hot to touch. The patient self-treated with ADVIL. In the middle of the night on 14-AUG-2012, "the fever broke and he was sweating". That morning, the patient "felt washed out" but the injection site redness was resolved. At the time of the report, the patient's outcome for the site of the injection was sore/injection site had a tennis ball-sized area of severe soreness, feels washed out, hot to touch at the injection site, swelling at injection site, had chills, felt feverish, weak, pale and sweating were recovering/resolving. The relatedness for the site of the injection was sore/injection site had a tennis ball-sized are of severe soreness, feels washed out, hot to touch at the injection site, swelling at injection site, redness at injection site, had chills, felt feverish, weak, pale and sweating is unknown for PNEUMOVAX 23. Additional information has been requested.
Information has been received from a reporting nurse via called correspondence concerning a 12 month old male with an upper respiratory infection "for a few days" who on 6/11/01 at 10:30, was vaccinated SC in the left arm with a 1st dose of varicella virus vaccine live and a 3rd dose SC in the left thigh of poliovirus vaccine. On 6/12/01, at 13:30, the pt experienced a "faint episode" white pushing a toy. It was reported that the pt "looked wobbly", went limp, experienced a "breathless" color of lips, turned purple and his head went back. It was noted that there was no foaming at the mouth. The experience lasted for a few minutes and then the pt took a breath. It was noted that there were no tonic-clonic movements and that the pt recovered from this experience. It was reported that the pt now has right otitis media. "Faint episode" and "breathless" were considered to be "Other Important Medical Events". No further information is available.
Severe joint pain, swollen joints & Covid not hardly move. Severe inflammation Internally swollen, Headaches, Severe Tinnitus in both ears, ringing in both ears. Muscle aches (false (+) lupus)
I was in November 2022 diagnosed with Addison's Disease.  In November of 2022 I started treatment for Addison's disease.  I was prescribed Hydrocortisone and this helped control my condition except for it has wiped out or made me fatigued, I call this phase one.  Once they diagnosed the Addison's condition they were hopeful the swelling in my lymph glands would go away but they did not, based on this they removed a lymph gland for a biopsy, that biopsy showed I have small B cell lymphoma  another rare disease.
2 weeks after receiving the booster 3rd shot. I developed Dermatographia and hives. Anything that touches my skin roughly or scrapes it I get hives and horrible itching. If I scratch my skin you can see the red lines and I develop itchy raised hives. They last for about a half hour then go away and come back if something touches my skin.
Patient returned to pharmacy 30 to 40 minutes following injection after sitting in the pharmacy area for 15 to 20 minutes and reported a little tightness at the top of the rib cage bottom of the neck. She did not report any shortness of breath/dizziness/light headedness, patient color was good, injection site was not inflamed and pulse was normal. Patient sat for 20 additional minutes and reported that tightness may have been elevating. I requested her two friends to take her to the nearest emergency room at Hospital for monitoring.
Pt received 4th dose of vax in 1990. Subsequently post vax, the pt's laboratory results indicated that she had a negative measles, mumps, and rubella titer.
This spontaneous report as received from a medical assistant refers to a 22 years old female patient. On 02-OCT-2012 the patient was vaccinated with dose 1 GARDASIL and on 13-DEC-2012 the patient was vaccinated with dose 2 GARDASIL intramuscular in her right arm. "Lot not reported as H014231, expiry date 21-NOV-2014, not valid for the product). No other co-suspects were reported. Concomitant medication included unspecified birth control pill. Five minutes after vaccination, the medical assistant noticed swelling at the injection site. The patient told her that the injection site was hot and burning. She then had tingling through her whole injection arm including her hand and wrist. About 15 minutes after vaccination, the hand felt better except for her little finger on her right hand. Ice was used as treatment. The outcome of the events was reported as recovering/resolving. The relatedness for the events is unknown for GARDASIL. Additional information has been requested.
Pt had signed up for a vaccine on 3/22/2021 and scheduled a follow up injection (2 part series) for 4/11/2021.  The pt no-showed the appointment and did not cancel it.   The pt made another 1st dose appointment on 3/31/2021 and did arrive at that appointment to receive his vaccine.  However, he also arrived at his 2nd vaccine dose appointment on 4/11/2021 as he had still not cancelled it.  He checked in and received the vaccine.    IT has been made aware of this glitch after the pt was discovered to be vaccinated and has already acted on it, cancelling all no show appointments so that it won't t happen again.
Swelling, redness, itchiness around injection site started 5 days after first dose of vaccine. Redness and swelling covered almost entire upper right arm.
Developed fever of 103, bodyaches, headache and cough. Tested positive for Flu.
At 17:32 pt reported to staff that she felt her lips were numb and swelling, in addition felt her cheeks were flushed. Pt taken to tx area, vitals taken (all within normal range) and pt given 50mg of Benadryl at 17:32 to treat symptoms. Pt denied any difficulty breathing. Pt stated she had sensation back in her lips at 17:43. Pt spouse arrival tx area @17:50 and agreed to drive patient home. Pt states she was much improved prior to departure @17:54. Pt was made aware of symptoms that would require her to respond to the Emergency Department, understanding verbalized. Patients' PCP, made aware. Aside from flushed cheeks, pt did not show apparent signs of allergic reaction aside from subjective symptoms, pt was in no acute distress, color within normal limits for ethnicity and pt was conversant. Lung sounds clear. Pt awake alert and oriented to self, situation, time and place.
Lymph nodes under arm are sore and nodes along collarbone are extremely sore.; Lymph nodes under arm are sore and nodes along collarbone are extremely sore and swollen; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN8737) via an unspecified route of administration in the left arm on 15Apr2021 at 07:00 (at the age of 52-year-old), as a single dose for COVID-19 immunisation. Medical history included depression. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received escitalopram (MANUFACTURER UNKNOWN), citalopram (MANUFACTURER UNKNOWN) and vortioxetine (MANUFACTURER UNKNOWN) for unspecified indication from unknown dates and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 16Mar2021 at 07:00 (at the age of 52-year-old), as a single dose for COVID-19 immunisation. On 17Apr2021, the patient experienced that lymph nodes under arm were sore and nodes along collarbone were extremely sore and swollen. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Within 5 minutes of administering vaccine, patient stated he felt hot in his face, described it as a wave of warmth that came over him suddenly. Patient also stated that his entire face was itching really badly. I had him sit in the chair closest to me and pointed my fan on him. I asked him if he had ever taken Benadryl liquid before, and he stated that he had. I told the patient I was going to give him 10ml  (25mg) of diphenhydramine liquid and he said that was ok. I also noticed that both of his arms had a splotchy rash from his hands up. I asked him if it was like that before I administered the vaccine, and he said no. He took the medicine and said he started feeling better within the next 10 minutes. He said he felt good enough to leave and go on to work. I told him he could stay as long as he needed to, and offered to give him more Benadryl, but he declined. He stated that he has Benadryl in his car because some of the cleaning chemicals at his work make him itch, so he keeps Benadryl in his car.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 30-OCT-2013, the patient was vaccinated with ZOSTAVAX (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-JUN-2016, the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
I got a flu shot last year. Got a flu a few weeks later; Initial information was received on 11-Nov-2020 regarding an unsolicited valid serious case received from a consumer or non-health care professional via social media.   This case involves a patient (unknown demographics) who experienced flu (influenza), after the patient received vaccine INFLUENZA VACCINE (flu shot).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency) the patient got INFLUENZA VACCINE (flu shot) last year and got a flu (influenza) a few weeks later.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
This spontaneous report was received from a physician via a company representative and refers to a "16 or 17 year old" female patient. The patient's concurrent conditions included an undiagnosed allergy (also reported as no drug/reactions allergies), medical history and concomitant medications were not provided. On an unspecified date, the patient was vaccinated with the first dose of GARDASIL (route of administration, anatomical location, lot number and expiration date were not provided). On 30-JUL-2015, the patient was vaccinated with the second dose of GARDASIL (route of administration, anatomical location, lot number and expiration date were not provided), immediately, the patient experienced dizziness and "10 or 15 minutes" following the vaccination, she could not see or hear, so her blood pressure was immediately measured and it was elevated an unspecified value. The patient was sent to the emergency department of an unspecified hospital, but she was not admitted as a patient. The patient reported, after she fully recovered and regained consciousness, that she experienced similar symptoms after she received the first dose of GARDASIL on an unspecified date. The outcome of the following events that the patient experienced with the first dose of GARDASIL: deafness transitory, dizziness, loss of consciousness, hypertension and blindness transient was reported as recovered/resolved on an unspecified date. The outcome of the following events that the patient experienced with the second dose of GARDASIL: deafness transitory, dizziness, loss of consciousness, hypertension and blindness transient was reported as recovered/resolved on 30-JUL-2015. The reporter did not assess the relatedness of deafness transitory, dizziness, loss of consciousness, hypertension and blindness transient with GARDASIL. The reporting physician believed that those symptoms could be related with an undiagnosed allergy. The patient's mother did not want her daughter to receive any additional doses of GARDASIL. Additional information has been requested.
Neck pain; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 63-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 (Lot number: EW0158, Expiration Date: 31Jul2021) at the age of 63 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: NECK PAIN (non-serious) with onset 13Apr2021, outcome "not recovered", described as "Neck pain". Therapeutic measures were taken as a result of neck pain.  Additional Information: The patient received concomitant product which included eye drops. The patient got her first shot on the 10th of April and then on the 13th, she started getting like a little bit of neck pain. On the 14th, it's really bad. So her neck really hurt and it was still like that. So she had six days with neck ache. She had no fever or anything like that it's just her neck was really bad. She just looked up for symptoms, it didn't say that she guessed the neck lymph node got swollen or she did not see any swelling but it hurt really bad so she didn't know. She asked if that was normal and if that happens. The patient stated that the start date of event was 4 days after the shot. As per patient, the event was persisting, worse persisting. She took some ibuprofen as treatment for the event.  No follow-up attempts are possible. No further information is expected.
Pneumonia; A spontaneous report was received from a consumer  concerning his mother, a 73-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pneumonia.  The patient's medical history included chronic obstructive pulmonary disease (COPD). Concomitant product use was not provided by the reporter.  On 19 Jan 2021, approximately five days prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Jan 2021, the patient developed a cough. The patient's temperature was recorded at 101 degrees Fahrenheit. The patient went to doctor. She was fatigued and coughing blood and was diagnosed with pneumonia. Treatment included azithromycin, and the patient seemed to improve.  On 05 Feb 2021, the patient developed a temperature of 101°F, coughed up blood and was very fatigued. She was diagnosed with pneumonia. Treatment for the event included levofloxacin.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, pneumonia, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of pneumonia, a causal relationship cannot be excluded. Patient's elderly age and medical history of COPD are considered a risk factors.
Patient developed diffuse urticarial rash, pharynx redness and lip angioedema approximately 45 minutes after injections. Patient was treated with BENADRYL and prednisolone. He was monitored for several hours in the ER and symptoms were completely resolved at discharge.
Fever or Chills  Cough  Muscle or body aches  Sore throat  Congestion or running nose
Congestion in chest, throat, sinuses. Headache. Coughing. General tiredness. Symptoms improved but not gone. Appeared 1 1/2 days after vaccination. No treatment sought yet.
HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and fatigue on MAR-2021. This report was non-serious.
Patient felt chest tightness, dizziness, left cheek/lip swelling and numbness.  Gave epi and transferred patient to the ED.
TIRED; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (TIRED) in a 91-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (TIRED). At the time of the report, FATIGUE (TIRED) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.   This case was linked to MOD-2021-046455, US-MODERNATX, INC.-MOD-2021-046640 (E2B Linked Report).; Sender's Comments:  MOD-2021-046455: US-MODERNATX, INC.-MOD-2021-046640:Aunt case
Hives or rash covered entire body (except face, hand and feet) starting the morning after receiving shot. Took Diphenhydramine HD 25 mg every 6 hours. As of 12/26/15 most of rash has diminished.
Red hives on left upper arm, treated with benadryl through 11/13/17 more soreness in arm than in past.
Day after shot I couldn't think or make decisions.  There was a small crisis at home and I couldn't think about what to do.  Tried googling and couldn't keep track of what I was doing, couldn't take in information, was confused.  Sat on the couch for 2 hours trying to think.  Didn't know what was happening.  Then got very sleepy.  Went to bed that night 2 hours early couldn't think or keep my eyes open.   The next day was the same, except wasn't sleepy and the confusion and trouble thinking was somewhat better.  The third day I was myself again.  Very scary.
huge local rxn rt arm fever, joint aches, noc sweats;itching @ site;
Patient received dose 1 of the Pfizer COVID vaccine (lot FF8839) at 1218 in her left arm while sitting in the zero-gravity chair as prophylaxis due to anxiety. At 1221, patient reported feeling dizzy and tingling in her face, arms, and legs, and her left arm felt cold. PHN and Paramedic approached to assess, laying the patient supine in the zero-gravity chair. Patient reported having had a similar reaction prior to amoxicillin. Vital signs: pulse 76, O2 99%, blood pressure 134/74, respirations 12. Patient reported allergies to ginger, cats, aspirin, and amoxicillin. Medical condition includes asthma but patient has not had to use an inhaler in over 30 years. Patient takes no medication. At 1225, PHN offered the patient Benadryl but patient declined. PHN educated patient on remaining onsite for 30min monitoring from time of symptom report, following up with provider and ER precautions. At 1230, patient reported she had only eaten a banana and coffee this morning. At 1235, vital signs: O2 99%, blood pressure 132/84, respirations 12, pulse 72. Patient ate a rice Krispy treat and drank water provided by the site. At 1240, PHN and Paramedic moved zero-gravity chair to seated position. Patient reported improvement in symptoms but feeling sweaty with remaining dizziness and tingling that was improving. At 1250, vital signs: O2 100%, respirations 12, blood pressure 128/78, pulse 70. Patient stood up, reported feeling cold and sweaty still. At 1254, patient left walking with steady gait, patient's friend to drive the patient home.
My right arm is on fire; There is a lump on my arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (My right arm is on fire) and AXILLARY MASS (There is a lump on my arm) in a patient of an unknown age and gender 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 BURNING SENSATION (My right arm is on fire) and AXILLARY MASS (There is a lump on my arm). At the time of the report, BURNING SENSATION (My right arm is on fire) and AXILLARY MASS (There is a lump on my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  No treatment information provided.
Patient presented today to the pharmacy (4/22/2021, 11:05 AM) with various bruises on the arm that received her second dose of the Moderna COVID-19 injection (left deltoid) both at the injection site and further down the upper arm. There was also redness and swelling, slight skin mottling as well. Patient did not report pain, but did report itching of the affected area. Patient said that this has been going on for the last few days. Patient was consulted to seek medical attention if there was any worsening of the affected area or if it did not seem to be healing within the next 2-3 days. Patient was also advised to let her primary care provider know about the reaction.
This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). On an unknown date, the patient experienced shingles shortly after receiving ZOSTAVAX. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.