chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient came into the pharmacy on Wednesday, 09/12/2018 for the second dose of the SHINGRIX immunization. After leaving the pharmacy, the patient went on a bike ride even though he had slight symptoms of a fever. The following morning at around 5:30am, the patient started experiencing flu-like symptoms with signs of fever, chills, and tiredness. Two days after, however, on 09/14/2018, the patient's immunized arm started swelling underneath the armpit under the lymph nodes. During a phone conversation, it was determined the patient should definitely see a physician. The patient immediately went to urgent care, but the physician practicing was via video and the patient alongside his wife felt as though his diagnosis and treatment plan wasn't sufficient. Upon arrival to the pharmacy to dispense an antibiotic, the area of swelling is significant. It is about 6 inches in length and at least 3-4 inches wide around the armpit area. It is easy to determine it as a superficial significant infection, which required more medical attention than determined at the urgent care. The patient went on 09/15/2018 to HealthCare Facility to consult a physician which practiced alongside the same group as his primary care physician. The physician practicing on the weekend provided a more complete treatment plan. He gave the patient doxycycline monohydrate 100mg bid to start (the patient was also prescribed cephalexin 500mg bid by the first urgent care visit), referred him to a surgeon for Monday. He will receive an ultrasound to determine if the infection is solid or liquid. If liquid, the infection will be drained and if it is solid it will be removed.
Patient describes having increased gas and belching starting two weeks after the first dose and has been continuing daily for the last few weeks. Reports no changes in diet or lifestyle.
Temp 104.5, given Tylenol PM. Increased temp x 3 days.
Case number PHEH2016US033874, is an initial spontaneous report received from a consumer (patient also a nurse) via pharmaceutical company (Pfizer reference number: 2016574499) on 28 Dec 2016. This report refers to a 37 years old female patient. Past medical history was not reported. Historical medication included as LYRICA. Concomitant medications included as LEXAPRO for depression and anxiety, LAMICTAL for bipolar, KLONOPIN for anxiety and trouble sleeping, AMBIEN, Vitamin B12 injection for critical vitamin B12 and Vitamin D for Vitamin D deficiency. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) in Oct 2014. On an unspecified date in Oct 2014, the patient had allergic reaction to flu shot. The patient also received with gabapentin for fibromyalgia at a dose of 50 mg three times a day in Nov 2014. The patient had a neurological symptoms from the flu shot in Nov 2014. The patient started gabapentin from 200mg, 300 mg to 600 mg and was maxed out to 800 mg a day dose. The dosage was so high, the patient felt very sedated, could not concentrate on an unspecified date in 2014. When patient sat down would be asleep in five minutes but the dose was decreased, it was not benefiting her physically and eventually was taking off of it. On an unknown date in 2014, the patient had rapid weight gain, within four months had put in 10 lbs. As the doses were increased the weight gain continued, thinks her depression was because she was gaining weight. Patient taking prednisone for weight gain but it did not help her. When patient got off the gabapentin she lost 15 lbs, dose was slowly titrated stopped taking in summer of 2015. On an unknown date, the patient had left side paralysis in left shoulder and arm where the injection was given and in left leg. Patient still having trouble with left leg, gait was not right still trips a lot. Patient also diagnosed with regional sympathetic dystrophy in left shoulder in Nov 2015. The outcome of the events sedation, could not concentrate, rapid weight gain and dose was decreased was not benefiting physically was reported as complete recovery on an unknown date and rest of events was not reported. The seriousness of the events was not reported. The causality of the events was not reported. Seriousness assessment of hemiplegia was upgraded to serious (medically significant) based on the NVS IME list. Seriousness assessment of the events sedation, complex regional pain syndrome, was upgraded to serious (medically significant) based on the information available in the source document.
Information has been received from a physician concerning a 12 month old female with no known allergies and a history of eczema (April 2003) who on19MAR2004 was vaccinated with a dose of measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine. On 19MAR2004, the pt was concomitantly vaccinated with a dose of varicella virus vaccine live. On 26MAR2004, the pt developed a fever of 102F and a rash on her trunk, arm and face. On 30MAR2004,the pt was seen in the office with the same symptoms. At the time of this report, no treatment was prescribed. Additional info has been requested.
burning w/urination & ejaculation approx 12-24 hr onset following inject; two pustules, tender to touch on penis
On 8/26 in the evening, bottom of my right foot was soar.   The next morning I noticed the upper outer side and bottom of my foot was black and blue.  My daughter, who had the vaccine same time as myself, showed me her legs were also black and blue.  I called her doctor and she instructed that I bring her to the emergency room for evaluation and decided to be evaluated myself.  After blood tests, we were sent home.
She had different allergies; This is a spontaneous report from a Pfizer Sponsored Program via a consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she had different allergies on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
worst flu he ever had.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "worst flu he ever had." Additional information: Reporter states that his friends both took Pfizer and one person had no side effects with the first or second shot and then her husband is very healthy and had no side effects on the first one, but the second one knocked him out for 3 or 4 days like the worst flu he ever had. Reporter states he had all the side effects and was in bed for a couple of days and took him out of commission. Reporter asks if this happens easily. Reporter also states he knows a few people that have taken the vaccine and had different conditions and that one person he knows was in remission for 30 years and it came back within 3 months, he had Guillain-Barre. Reporter asks if there is a chance the drug can cause autoimmune flare ups like Parkinsons or Guillain Barre. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "gastrointestinal reflux" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) in two weeks included: ASPIRIN LOW; OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2022) positive, notes: fatigue, chills- just like the symptoms he had the first day he tested positive and he developed a cough; (26Jul2022) Negative, notes: On the 2nd day post-treatment, I tested negative (at-home rapid test for Covid); (29Jul2022) positive, notes: On the 5th day I woke up feeling fatigued and had nasal congestion and tested positive for Covid 19 (at home rapid test). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course reported as Patient tested positive for Covid-19 on 20Jul2022. That day he felt fatigued, feverish and had chills. He was prescribed Paxlovid that morning and began taking it immediately. Patient Covid-19 symptoms started to improve on the 2nd day of Paxlovid treatment, but he began to have a bad taste in his mouth. On subsequent days he would feel energetic upon waking and then fatigued after taking the morning dose of Paxlovid. Upon completing the 5 day treatment, treatment stop date was 24Jul2022, he felt normal and energetic for 3 days. On the 2nd day post-treatment, he tested negative (at-home rapid test for Covid). He continued to mask per CDC guidelines and distance from family, who also masked. On the 4th day post-treatment he experienced a runny nose. On the 5th day he woke up feeling fatigued and had nasal congestion and tested positive for Covid-19 (athome rapid test). He slept for most of that day, and the next day fatigue, chills- just like the symptoms he had the first day he tested positive and he developed a cough. Paxlovid rebound.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 29-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J003453, expiry date: 25-MAR-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
bruising; she discovered after getting the vaccine that she was pregnant.; This spontaneous report has been received from a 29 years old female consumer referring to herself. The patient's medical history, concomitant medication and drug reactions or allergies were not provided. The patient's history of previous pregnancy and live births were not provided.  On an unknown date (reported as few years ago), the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, strength, route, lot# and expiration date unknown) for prophylaxis. The patient did not have any of the paperwork. The patient became pregnant with last menstrual period (LMP) of 30-APR-2021 and estimated date of delivery (EDD) of 04-FEB-2022. On 24-MAY-2021, the patient was vaccinated with the second dose in a 2 part series of varicella virus vaccine live (Oka/Merck) (VARIVAX) (injectable; dose, strength, lot# and expiration date unknown) for prophylaxis in the outer portion of the left arm (Exposure during pregnancy). After vaccination, the patient discovered she was pregnant. On the same day, the patient experienced bruising. The patient has not used any treatments for the pregnancy or the bruising. Until the reporting date (reported as so far), the patient was everything ok with the pregnant. The patient still had some bruising.  The causality between the event of bruising and varicella virus vaccine live (Oka/Merck) (VARIVAX) was not provided.
Flu-like symptoms; Slight headache; 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 INFLUENZA LIKE ILLNESS (Flu-like symptoms) and HEADACHE (Slight headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and HEADACHE (Slight headache). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment drugs were not reported.
Information has been received from a registered nurse concerning an 18 year old female who in August 2007, "last week" was vaccinated with a first dose of Gardasil (lot # unknown) 0.5mL injection.  Concomitant vaccinations included MENACTRA.  In August 2007, "last week" the patient fainted after receiving her first dose of Gardasil.  Medical attention was sought.  At the time of reporting it is unknown if the patient had recovered.  No additional information was provided.  Additional information has been requested.
Information regarding PREVNAR 13 was received from a consumer regarding a 16-month-old female patient who was reported to be not acting like herself, straining to have a bowel movement because she was severely constipated and stool came out as half the size of M & M and hard like rock. At 16 months of age, the patient received the first dose on 19-Aug-2010. MEDICAL HISTORY: The patient previously experienced no adverse event while PREVNAR. The patient had previously received 4 doses of PREVNAR prior to 18 months. PRODUCT DETAILS: Indication for PREVNAR 13 was immunization. Product was administered on 19-Aug-2010. Dose regimen was 1 dose 1 time per day (intramuscular). CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: In Aug-2010, a few days after receiving PREVNAR 13, The patient was not acting like herself, and was straining to have a bowel movement because she was severely constipated. The mother noted that "nothing had changed in the patient's diet". The mother gave the patient more water, apple and prune juice and fiber but the patient remained constipated. The mother reported she now has to give the patient enema, but the patient's stool still came out as half sized of an M & M and was hard like a rock. The events persisted. No additional information was available at the time of this report. Follow-up (10Nov2010): Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up CIOMS I or MedWatch report may indicate in the appropriate field that it is an initial report. This is a spontaneous follow-up report from a contactable nurse. The patient's surname, the name of the nurse who administered the vaccine, the Country where the vaccine was administered and the vaccine Lot # (913955) were additionally provided. The patient was born at full term. The patient's mom called for phone advice for her baby's constipation on 07Oct2010 and stated her child had had problem with constipation since 19Aug2010. The patient's birth weight was 6.7 oz, head circumference was 33 cm and she was 19 inches high. she had no siblings. The patient's mom was given advice for constipation on 07Oct2010, she was advised to start the child on MIRALAY, to stop potty training for 3 months, which was considered as a risk factor that may have contributed to the patient's adverse event and to continue high fibers diet and increase fluid intake. No further concerns about constipation have been received in the nurse's office after that time.
4 days post vax the pt developed generalized vesicular rash lesions, also in his mouth and ears. Pt had a high fever of greater than 101F and experienced approximately 24 - 36 hours of vomiting. The vesicles were too numerous to count and they erupted the next day.
Progress Notes; Encounter Date: 10/25/2018; Patient ID: 65 y.o. Female; Chief Complaint: ALLERGIC REACTION (flu shot site left arm). This is a new problem. Pertinent negatives include no abdominal pain, chest pain, coughing, vomiting or wheezing. Patient had a flu shot on the left arm. Patient presented with symptoms of redness painful at surgical site. Patient mention she is feeling more fatigued and fever since yesterday. Patient has no documented fever. Redness, warm to touch, tenderness; Assessment / Plan: Cellulitis of left upper extremity localized reaction at injection site; Start antibiotics as prescribed; Cold pack prn; Activity as needed.
Child was given pneumoccal 23 instead of Prevnar 13.  Mother reports no adverse effect.  Mother was instructed to bring child in  for Prevnar 13 in 2 months.
Patient reports of sore arm extending over a long period of time. She stated that she still cannot sleep on that arm and the pain sometimes radiates to her shoulder and rib area. She stated she is able to live with the pain but just wanted to report that it is still ongoing. She stated she had her primary physician take a look at the arm and did not see any visible problems.
Patient is a 74 year old female with PMH of morbid obesity and seizure disorder who presented to the ER on 2/13/2021 with weakness and fever.  Patient tested positive for COVID-19 on 2/13 and was treated with a five day course of oral dexamethasone and remdesivir. Antibiotics were started on admission, but serial chest x-rays were mostly stable and all culture results remained negative. Antibiotics were discontinued on 2/15. Patient discharged to home on 2/18/2021
Real itchy arm / big part of arm is all itchy; Big part of arm is all red / red area size of hand on arm; Upper shoulder has little bumps; Headache; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Real itchy arm / big part of arm is all itchy), ERYTHEMA (Big part of arm is all red / red area size of hand on arm), RASH (Upper shoulder has little bumps), HEADACHE (Headache) and FATIGUE (Fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever). On 07-Apr-2021, the patient experienced PRURITUS (Real itchy arm / big part of arm is all itchy), ERYTHEMA (Big part of arm is all red / red area size of hand on arm) and RASH (Upper shoulder has little bumps). On 01-Apr-2021, HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever) had resolved. At the time of the report, PRURITUS (Real itchy arm / big part of arm is all itchy), ERYTHEMA (Big part of arm is all red / red area size of hand on arm) and RASH (Upper shoulder has little bumps) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Hypertension-Severe
Information was received from a nurse concerning a one year old female with no known allergies who on 07 OCT 2004 was vaccinated with MMR.  Concomitant therapy that day included Varicella virus vaccine.  On 07 OCT 2004 the patient was placed on a 10 day course of AMOXIL.  On 17 OCT 2004 the patient broke out in a rash.  It was reported that "it does not sound like Varicella virus vaccine live".  No fever was present.  It was reported that the child to be seem by a dermatologist as soon as possible.  Unspecified medical attention was sought.  No product quality complaint involved.
Received #1 dose as stated.  Next day, 1/27/21, 9:00am , had mild joint pain to both legs, & arms, & slightly tired.  Shortly after that , while driving, had nausea, & muscle aches to legs & arms.  Reaching family members home, could barely carry bags with each arm, due to pain in joints, and to muscles, getting worse.  Through the next 6 hrs. had moderate to severe pain to joints, & muscles & gradually severe fatigue. Took 1 Tylenol 650 mg for pain.   Also, checked temperature thru out this time, with only mild 99.5 temp.  Vaccine site gradually became swollen, with increased pain.  Was doing work on computer, but could not continue, so left for my home, & went to bed, to sleep.  Lt.  Arm started becoming red, with severe soreness & swelling by 1/28/21, 2 days after vaccine.  Vaccine was given very high on my arm, almost shoulder area.  All Symptoms continued for about 10 days, including  to vaccine arm, which continued with redness & soreness for 2 weeks.   My physician was notified.   She advised NSAID before #2 dose, but I already take NSAID daily (Meloxicam), so don't think I can take another NSAID.  I have been taking Tylenol 650mg at least twice a day, for increased joint & muscle pain, since vaccine.  My 2nd dose, originally scheduled for 2/23/21 has been rescheduled to 2/27/21 due to no vaccines available.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 29-SEP-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K019502 with expiration date 14-FEB-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Symptoms started with extreme fatigue, followed by nausea and fever. I slept for several hours and woke with a sharp pain in my right side. I still felt extremely exhausted, and was so weak and nauseated that I couldn't get out of bed. I finally reported to OB triage, and after a normal CBC was released. I slept the rest of the day, but it was a full week before my fatigue subsided.
Sore joints knees and ankles Shakes Chills Headache Fever 101.7 Tired Sore throat Sore arm from injection site
Red areas, purpura and blisters on face, back, abd and chest. Done + shingles.
Bell's Palsy of 7th Nerve, treatment Prednisone 60 mg QD x 7 days, outcome TBD
5/10 min after shot I started sweating profusely and y body temp felt really hot, I then started feeling faint and my vision went blurry and I had stabbing pains in both arms. This lasted 10 minutes and was extremely uncomfortable, by the time medics reached the scene I was okay and the only symptom that remained was the stabbing pains.