chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came back to the pharmacy on 11/22/17 at around 10:35am seeking advice regarding new ringing in his ears that started on 11/14/17 approximately one day after his influenza vaccination on 11/13/17. He claims that the ringing comes and goes and that he thinks it is getting better but he is not sure and that it is "annoying" to him. He also said that his wife could see evidence of ear wax buildup and he thinks that could be contributing to the problem as well. He said that he re-read the VIS that was provided to him during the time of vaccination and he did not see where ringing of the ears was a common side effect. I also informed him that ringing of the ears was not common and that I would report his adverse event per our protocol. He did not seem too worried but just wanted to make sure there were no long term effects from getting this particular flu shot. I additionally informed him that he is the first person to have this side effect from this batch/lot of FLUZONE HD that we have been providing this flu season. I did end up providing him with DEBROX to potentially help with the ear wax and I also asked him to keep me updated with his condition should it get worse.
This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with first dose of VARIVAX dose route and frequency unknown. On 12-APR-2013 the patient was vaccinated with improperly stored VARIVAX dose 2, lot#:0610AE. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Persistent weakness and pain in left arm, at site of injection.  Can't reach across to right shoulder or use loppers, even 3 months later, without significant pain.
Patient reported on schedule and by registration as a first dose Moderna. Pt reported via phone and in person to providers as needing Moderna. Pt was given Moderna vaccine. After leaving clinic and returning home patient contacted provider and reported first dosing was with Pizer.
Myalgia mild to moderate  Headache moderate Ear ache mild to moderate  All over a 36  - 48 hour time period
Patient reports warmth, redness, swelling, and itching at injection site. Symptoms did not start until 8 days after injection. Patient denies rash or any air compromises
Herpes Zoster; This initial spontaneous report has been received from a lawyer regarding a case in litigation referring to a 63-year-old male patient. No information was provided regarding concomitant medications, concurrent conditions or medical history.     On an unspecified date in 2015, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine for the long-term prevention of shingles and zoster-related conditions (dose, route, and lot number not provided).         On an unknown date, the patient experienced herpes zoster and was treated by a healthcare provider. The outcome of the events was unknown. Causality assessment was related.
Immediate soreness at site, body aches, generalized malaise, headache, fever up to 102, nausea and vomiting, fatigue, headache
9/27/2007 per mother child woke 830am hives over body - arrived in office. No hives - after 25 minutes. Hives again - below diaper on back.
severe fatigue; Nausea/felt yuck; a little sluggish; sore arm; she was out cold; slept for 24 hours off; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 16:30 (Lot number: EN6208, Expiration Date: 30Jun2021) at the age of 47 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Verbatim: Rheumatoid arthritis; "Renal disorder" (unspecified if ongoing), notes: Verbatim: Kidney disorder; "immunocompromised" (unspecified if ongoing); "she was a cancer patient" (unspecified if ongoing). Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis Dosage text: once a week injection. The patient stated stating her reaction to the vaccine is a little abnormal or out of what she is expecting. She never has issues with vaccines, she gets all of her flu vaccines every year. She takes a biologic for rheumatoid arthritis and has kidney issues as well. Her main concern is the severe fatigue she experienced after the first shot. She actually did get corona. However, she doesn't have any fever. She's been checking her temperature- no fever, no swelling of lymph nodes, it's definitely not coronavirus, she is very sure of that. States that she was a cancer patient. When speaking of her kidney disorder, she clarifies she has an inability to process electrolytes. Kidney disease was one of the qualifying factors for receiving the COVID-19 vaccine. States that it is kidney damage and that it is a tubule processing thing. The following information was reported: FATIGUE (non-serious), outcome "recovering", described as "severe fatigue"; NAUSEA (non-serious), outcome "recovering", described as "Nausea/felt yuck"; SLUGGISHNESS (non-serious), outcome "recovering", described as "a little sluggish"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "she was out cold"; HYPERSOMNIA (non-serious), outcome "unknown", described as "slept for 24 hours off". The patient was treated with Pepto on hand and Ondansetron. Therapeutic measures were taken as a result of nausea.  No follow-up attempts are possible. No further information is expected
after waiting the 15 minutes patient started feeling palpitations. Registered Nurse took her pulse and noticed it was 120. Pt stated she felt dizzy but nothing else. walked pt over to vehicle where her husband was parked. pt decided to be taken to ED in her own vehicle for further eval
Moderva Covid-19 Vaccine  - extremely high fever (102-103F) during more than 20 hours. Chill. And extreme sweatiness on the day after with mild fever.  - fever relief medicine decreased fever only for ~ 2 hours everytime it was taken, being necessary to repeat each 4 hours during 2 days.
Case had COVID-19 in November 2020 as part of an outbreak in the SNF she lives in. She recovered then received her first COVID-19 vaccination on 1/4/21. She received her 2nd dose of Moderna on 2/1/21. On 4/11/21 she became ill and was transferred to the hospital where she tested PCR positive for COVID-19. She continued to decline and was intubated. She died on 4/28/21 while still in the hospital. The diagnosis on her death summary from the hospital is COVID-19 pneumonia.
Initial report was received 15 April 2011 from a consumer, who is also the patient. This case involved an inappropriate schedule of vaccine administered. A 47-year-old female patient who had a history of MS (multiple sclerosis), had received a third dose injection of TDAP vaccine during November 2010 (manufacturer, lot number, route, site and exact date of administration unknown). During January 2011 (exact date not reported) the patient experienced an exacerbation of her MS. According to the patient, her neurologist stated that her MS was exacerbated based upon MRI results from January 2011. The patient had received two prior doses of TDAP vaccine (manufacturer and lot numbers unknown) during June 2009 and April 2010 respectively. No additional information was provided at the time of the report. Documents held by sender: None.
This spontaneous report was received from registered nurse, concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 27-APR-2017, the patient was vaccinated with a dose of M-M-R II (strength, dose, lot# and expiration date were unknown), intramuscularly in the left thigh for prophylaxis. It was reported that the M-M-R II was administered with an sterile diluent. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
flaming red rash across shoulder and biceps, hot to touch, occurred less than 24 hours of injection Disagnosed as cellutis, being treated currently with Bactrim and prednisolone.
Patient received Fluad flu shot on 9/22/21; after receiving vaccine, patient's wife stated that he already received flu shot at pharmacy.  Patient was screened appropriately and was aware of what he was receiving.  Patient received Afluria Quad at pharmacy on 9/10/21.  Dr. (patient PCP) notified 9/22/21.
I was have abdomal in the center of my stomach it was very sharp it turns out I was very constipated
Information has been received from a licensed practical nurse for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female with urinary tract infection and penicillin reaction/allergy with no pertinent medical history who on 10-JUL-2009 was intramuscularly vaccinated with the first dose of GARDASIL (Lot #662300/1674X) and is now pregnant. Concomitant therapy included PRENATE DHA and MACROBID. It was reported that the patient's last menstrual period (LMP) was 21-JUN-2009 and the estimated date of delivery (EDD) is 28-MAR-2010, the estimated conception date was 05-JUL-2009. It was also reported that the patient had no previous pregnancies or live births. On 08-SEP-2009 an ultrasound and an integrated screen were performed. The results were normal for both. On 12-OCT-2009, an integrated screen was performed again and was reported as normal. The patient sought medical attention by an office visit. There was no adverse effects reported. Follow up information has been received from the licensed practical nurse regarding the 26 year old female patient with penicillin allergy, hypothyroidism and hypertension with no previous pregnancies or live births who on 10-JUL-2009 was vaccinated with GARDASIL. Concomitant therapy included PRENATE. It was reported that the patient experienced hypertension, urinary tract infection, nausea and vomiting during pregnancy. On 14-AUG-2009 a Cystic fibrosis test was performed, the result was negative. On 19-AUG-2009, treatment with MACROBID was discontinued. On 08-SEP-2009 and on 12-OCT-2009, Maternal Serum Alpha Fetoprotein (MSAFP) test were performed, the results were within normal limits. On 18-JAN-2010, the patient was treated with ZOFRAN for nausea and vomiting. It was reported that on 17-MAR-2010, at 38 weeks and 3 days of gestation, the patient delivered a normal male baby (weight 4315 grams, the length was 20.5 inches, APGAR score was 8/9). The patient did not have complications during labor or delivery. The baby did not have congenital anomalies. There were no complications or abnormalities. At the time of the report, the outcome of the patient's worsening hypertension, nausea, vomiting, and UTI were unknown. Additional information is not expected.
This spontaneous report as received from a medical assistant via a sales representative, refers to a male patient of unknown age. On an unknown date the patient received a first dose of GARDASIL , (route, lot # and expiration date was not provided). Co-suspect therapy was not provided. Concomitant therapy included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (therapy unspecified) and meningococcal vaccine (unspecified). It was reported that the patient fainted after received the first dose of GARDASIL on an unknown date. The patient recovered on an unknown date. The relatedness between the event and suspect therapy was unknown. This is one of several reports received from the same source. Additional information has been requested.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Medium, Additional Details: unsure if actual seizure. EMS was called, pts bp, pulse and HR normal when they arrived. pt agreed to go to the hospital for further evaluation.
Patient developed a high fever on 3/5/02. Developed febrile seizure, Seen in ER-looked well.
LOCALIZED SWELLING AND PAIN TO THE INJECTION SITE.  STARTED WITHIN 2 MINUTES OF GIVING VACCINE AND PAIN WENT AWAY AFTER APPROXIMATELY 10 MINTUES
Fever up to 102.5, swelling of hands, feet, legs and forearms, whining and crying, decreased appetite, decreased fluid intake, blotchy bluish skin color of hands and forearms.  Patient treated with Rocephin IM prophylactically for possible "blood infection".
715AM  29JAN98 pt recv vax & 730AM itching, sneezing, hives;815AM DPH;915AM hives resolved, mild conjunctival inject;no wheezing;no dysphagia;
Missed the 2nd dose of Moderna vaccine and was scheduled by the end of June; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed the 2nd dose of Moderna vaccine and was scheduled by the end of June) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed the 2nd dose of Moderna vaccine and was scheduled by the end of June). On 31-Dec-2020, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed the 2nd dose of Moderna vaccine and was scheduled by the end of June) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  On ??-Jun-2021, patient received the second dose of Moderna vaccine at Walgreens.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Patient demographics and event code was updated.
This spontaneous report has been received from a physician assistant via  company representative referring to a patient of unknown age and gender. Information regarding medical history, drug reactions, allergies, concurrent conditions and concomitant therapies was not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX, (strength, route of administration, frequency, lot#, dose and expiration date were not reported) for prophylaxis.  On an unknown date, the patient experienced injection site reaction after the vaccination. Product quality complaint was not involved. At the time of reporting the outcome of injection site reaction was unknown.  The relatedness between the injection site reaction and ZOSTAVAX, was not provided. Additional information is not expected because the reporter did not want to be contacted.
shortness of breath; faster heartbeat; This case was reported by a consumer via interactive digital media and described the occurrence of shortness of breath in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th July 2020 01:30, the patient received Shingrix. On 10th July 2020, less than a day after receiving Shingrix, the patient experienced shortness of breath and heartbeats increased. On an unknown date, the outcome of the shortness of breath and heartbeats increased were unknown.   It was unknown if the reporter considered the shortness of breath and heartbeats increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per the vaccine indication. After receiving Shingrix, the patient experianced shortness of breath and faster heartbeat.
Vaccine was given almost 25 hours after vial had been at room temperature. Patient is not currently experiencing any side effects.
Pain starting in both legs the day after the vaccine(Tuesday) and fever of 100.6 Later that night the fever broke and the pain persisted in right leg . He took tylenol to ease pain.   Wednesday the pain persisted and  he continued with tylenol .  Thursday am woke to find the leg was swollen and painful to the point of going to the er.
Entire left and right arm tight the day after shot, fingertips tingles. Lasted 2 days. No treatment.
Information has been received from a registered nurse concerning a 19 year old female who on 04-APR-2007 was vaccinated with first dose of GARDASIL (route not reported, lot number 655324/0088U). The registered nurse reported that the patient experienced seizure-like activity that occurred a few days after the first dose was given to the patient. It was reported that the patient received the second dose of GARDASIL (route not reported, lot number 655324/ 65863/1063U). It was unspecified if the patient had the same symptoms after she received the second dose because the registered nurse had not heard from the patient since her check-up on 08-APR-2007. The registered nurse reported that therapy with GARDASIL was discontinued on 26-OCT-2007. The patient sought medical attention by contacting the nurse. Upon internal review, seizure like activity was determined to be an other important medical event. Additional information has been requested.
Left hip very sore. Lost muscle control. It was like sciatica of the hip. Also a few stomach muscles were sore/stiff like the day after a workout.
Starting about 4 hours after vaccine administration, patient started to experience the following at the site of administration: arm soreness, hot to touch, redness and swelling which continued for 5 days. Patient reported these to us on 9/1/23 by which all her symptoms had resolved completely with once exception: a puffy, soft, painless lump just below the elbow, not bothersome but patient believes it was not there prior to vaccine administration. Patient said she will see her doctor about it.
Patient reports that pain started immediately after receiving injection  and has worsened each day.  No injection site pain or redness, just pain from top of shoulder down to elbow.  Pt has taken over the counter ibuprofen and reports that pain is affecting her sleep. Patient presented to the ER on 11/26/13 (19 days post injection) and MD did X-ray. She reports that the doctor told her that he "couldn't be sure it was 100% related to the flu shot".  Pt. received a cortisone injection in the hip and Rx for Lortab.
I have Parasites inside my blood street some are small and some are much bigger; This is a spontaneous report from a contactable other healthcare professional, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 23Mar2021 at 17:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux and two hernias. Concomitant medications included calcium carbonate (TUMS), aluminum hydroxide; magnesium hydroxide; simeticone  (MYLANTA) and simeticone (GAS X); all from unknown dates for unknown indications. The patient had no known allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Mar2021 at 17:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Mar2021 at 02:30, the patient reported that she had parasites inside her blood stream (street) some are small and some are much bigger. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken for the reported event. The clinical outcome of the event parasites inside blood street some are small and some are much bigger was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Adverse Event: PT reported dizziness after first dose of Pfizer. No LOC. PT also reported having no breakfast this morning. Treatment: Aid was summoned and assessed PT. Vital signs obtained (BP 108/80, HR 80, SPO2 99%).  Juice provided. PT education provided by safety officer/RN. PT plans to f/u with primary care.  Outcome: PT reported s/s improved after juice. PT medically cleared by EMS, brother to drive PT home.
While I was at the Health Department getting my 2nd vaccine I let the nurse know about the severe itching around the injection site of the 1st vaccine so it was decided to go ahead with the 2nd vaccine and it was injected into the opposite arm. Around 10 hours after receiving the injection my arm became red, itchy, and began to swell. I went to bed and when I woke up around 8AM on 02/20/21 my arm was extremely sore and then upon inspection of the site my upper arm was extremely swollen, red, sore, and itchy. I did take Benadryl to help with the symptoms. The swelling was so large it took a week for it to return to normal and then another few days for the soreness and itching to completely resolve.
I received a Pfizer booster yesterday 1/10/22 and today have a low temp with 5/10 pain in my axilla at rest and my left arm is numb with radiating discomfort into my left breast, tightness in my chest and numbness into my left jaw.
Around 5am in the morning, Perfuse watery eyes, continuous clear nasal mucus, extreme pain and burning in both upper eyelids, and a "sensation on eyeballs as if there are splinters in it as if there is something in them" and sensitivity to light. Patient then took chlorpheniramine 2mg antihistamine. As per patient, he does not suffer from allergies. "It may have been a virus and has nothing to do with this adverse reaction" As per patient, he also received a influenza vaccination about two weeks before and had flu like symptoms on the night of the flu vaccination.
Received ENERGIX B vaccine on 3/17/10. Approx 24 hours later mother noticed circular area of redness at site of vaccination. No raised swelling. No fever, irritability, or diminished movement of leg. Local reaction confluent redness round mildly induration 6 cm diameter.
Pt admitted for high fever, extremely fussy, irritability, unconsolable crying for 2 hr period; Cry was high pitched-whine; IV therapyw/antibiotics;
Patient began to experience tingling and chills in the  middle of her spine almost immediately after obtaining the vaccine. She was seen in the ER for evaluation the next day. Her symptoms shortly improved