chrisvoncsefalvay/vaers-outcomes huggingface dataset:
p/vax pt c/o weight loss; arthritis symptoms; h/a; tiredness & upset stomach; took ADVIL; it helped a little; Medical record of April 27, 1999 noted that the patient complained of pain in both breasts. The diagnosis was "rule out breast mass". April 3, 2000 medical record noted "lumpy left breast". The vaccinee was diagnosed with "rule out breast mass" and PREMPRO was prescribed. May 2, 2000 physical therapy note: The vaccinee complained of pain in both hands, lumbar spine, both hips, both feet, toes, callus muscles, adn forearm muscles. Patient also had a "constant" headache and weak grip. The vaccinee stated that these symptoms were caused by "medication". The vaccinee had positive myofascial restrictions, normal upper and lower extremity range of motion, and normal ankle strength. May 30, 2000 physical therapy report: the vaccinee received six sessions of physical therapy. Treatment protocol consisted of soft tissue techniques, range of motion, stretching, moist heat, "E-stim", paraffin to bilateral hands, home exercise program, and a comprehensive stretching and strengthening pool program. At discharge, the vaccinee reported good/bad days. Pain complaints fluctuated in intensity and region. Objectively, active range of motion was normal throughout all tested regions. Gross strength was within functional limits. Special testing revealed scoliosis. Myofascial restrictions were significant throughout T/&/L/S (thoracic and lumbar spine) At discharge, the vaccinee was encouraged to manage her condition with stretching and strengthening, including a pool program. It was recommended that patient perform light impact activities, i.e. walking, swimming, for cardiovascular fitness. Recommendation: discharge with home exercises program. June 29, 2000 medical record noted"vaginal lump". The vaccinee was diagnoses with left Bartholin abscess and underwent marsupialization of the left Bartholin abscess on July 1, 2000. The patient tolerated the procedure well. The Bartholin biopsy abscess showed "fragments of fibroconnective tissue with acute and chronic inflammation; no epithelial lining seen." Please note that the events of "lumpy breast mass" and "Bartholin abscess" were not reported as adverse events due to vaccine administration, but were found during the course of review of the patient's health records. Therefore they are not listed as adverse events. As of June 12, 2001, the outcome of the events is unknown. The adverse events of 'headache' and 'osteoarthritis' do not meet ICN serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter. Follow up received 7/2001.
Pain, redness, swelling at injection site. Severe all-over body ache, shivering, fatigue, headache, 24 hours.
Patient had redness, soreness and swelling at injection site initially that resolved after 3 days, then starting 6 days after vaccine swelling returned at injection site and it was inflamed and warm to the touch.  The patient tried topical Benadryl and found no relief, then called the pharmacy 3/11/21 to report the issue.  Pharmacy advised patient to seek care from her doctor or walk in clinic.
Developed a big lump that is hot and red at injection site. This was 1 week and 1 day after injection
On June 11, 2021 I had to get a CT scan of my abdomen. After I was given contrast via IV  through my  right arm I started having tremors in my left hand and left foot.    Tremors in my hand resolved within one hour. Tremors in my foot lasted three days four days.  Additionally my foot felt like it was cramping.   This incident occurred after my first vaccination.  I am reporting this as this unusual event is possibly related.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  HYPOXIA  11/14/2022 --  RECURRENCE OF SAME SYMPTOMS
After expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (After expiration date). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (After expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patients have received doses of the Moderna covid-19 vaccine after the published expiration date between 28OCT2021 and 14DEC2021.  Date the vial(s) were moved from freezer to refrigerated conditions (calendar date is required): 04NOV2021  No concomitant medication information was provided. No treatment information was provided.
Patient received vaccine on 12/9/2019 in the afternoon.  Early the next morning she started having fever, chills, redness and swelling at injection site.  She was nauseated and vomited once.  She had a fever at school that day and was sent home.  Seen in  our office on 12/11/2019 and still had some redness and induration at injection site.  Other symptoms had subsided
Fever ,chills , fatigue  , loss of smell for the first 2 days  Constipation
Disseminated Intravascular Coagulation Platelets = 19 Elevated Liver Enzymes. Bleeding coagulopathy Anemia Tachycardia Elevated white blood count
phlegm; coughing; very low blood oxygen; Drug use for unapproved indication; This non-serious case was reported by a consumer and described the occurrence of phlegm in a 69-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included diabetes and bronchitis (developed bronchitis). Concomitant products included semaglutide (Rybelsus).   On 19-SEP-2023, the patient received Arexvy. On 19-SEP-2023, an unknown time after receiving Arexvy, the patient experienced drug use in unapproved indication (Verbatim: Product use in unapproved indication). On 29-SEP-2023, the patient experienced phlegm (Verbatim: phlegm), cough (Verbatim: coughing) and oxygen saturation decreased (Verbatim: very low blood oxygen). The outcome of the phlegm, cough and oxygen saturation decreased were not resolved and the outcome of the drug use in unapproved indication was unknown.   It was unknown if the reporter considered the phlegm, cough and oxygen saturation decreased to be related to Arexvy.     It was unknown if the company considered the phlegm, cough and oxygen saturation decreased to be related to Arexvy.   Additional Information: GSK receipt date: 16-Oct-2023 The reporter reported seriousness for phlegm, coughing and very low blood oxygen was intervention required. The reporter consented to follow-up. The patient received a dose of Arexvy for bronchitis, which led to drug use for unapproved indication.
pt saw MD 8MAY97 lt arm swelled to elbow, t103.6 made huge knot-very red;MD gave allergy meds (doesn't know name);pt told very allergic to tetanus & not to take it anymore;
4/8/21-Very stiff neck, pain level 8. Hard to move. Improved the following day. Did not take NSAIDS. Developed constipation. Developed a migraine (to be expected) 4/10/21-developed "Covid Arm" rash. Raised red itchy rash.  4/11/21-rash grew to size of silver dollar, didn't respond to topical hydrocortisone, took benadryl. 4/12/21-rash has settled down some but is still present. Having continued issues with constipation (was not an issue until the vaccine). Period is late, not at risk for being pregnant.
Weakness and shaking in morning. Persistent headache increasing to severe throughout day.  Mild nausea, chills, body aches. Neck stiffness. Severe headache causing dizziness. Treatment: acetaminophen 1000mg morning, ibuprofen 800mg evening.
This spontaneous report was received from a healthcare worker regarding a 9 month old infant patient of unknown gender. Concurrent conditions and medical history were unknown. On an unknown date the infant patient was vaccinated with a pediatric dose of VAQTA 25/0.5 (units not reported) lot # L018499 expiry date- 25-FEB-2017 in error. Concomitant medications were unknown. The reporter did not provide the causality between the event and the suspect therapy. No adverse event was reported. No PQC involved. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of therapeutic response decreased in a 20-year-old male patient who received Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Hepatitis B vaccine. Additional details were provided as follows: The health care professional stated that the patient she assumed completed the Hepatitis B series (did not confirm if it was ENGERIX-B) as a baby needed to get evaluated for Hepatitis B protection for nursing. Last month the patient's titers came back low so physician's office gave a Hepatitis B shot (did not confirm it was ENGERIX-B) to the patient.
Hive-like rash over chest and neck and under arms bilaterllay, developed 1 week after 2nd dose of Gardasil vaccine
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional.   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004183, MCM-004186, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
10 hours after the vaccine, shoulder/arm area suddenly became very sore.  A reddish circle appeared around the vaccination site and it appeared to be raised at the center.  My arm was extremely sore for 24 hours, then slowly the redness and pain subsided.  Also had a mild head ache for 2 days. No need for any medications.
Bad joint; muscle pain; there was some discomfort; a miserable case of the flu; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient herself). A 76-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Batch/Lot Number: EN6207 Expiration date: Unknown) via an unspecified route of administration, in Left arm on 11Mar2021 11:15 AM (at the age of 76-year-old) as dose 1, single for covid-19 immunization. Patients medical history included diabetes mellitus and covid-19 (prior vaccination) from an unknown date and unknown if ongoing. Patient does not have any known allergy and she was not tested for covid-19 post vaccination. If patient received other vaccine in four weeks was unknown and received any other medications in two weeks was unspecified (Too many for this space). On 12Mar2021 12.00 AM patient experienced Bad joint and muscle pain, Like a miserable case of the flu without the sour stomach. It was like this the day after the shot, On the next day, there was some discomfort, but not like the day after. Patient did not receive any treatment. Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
Pt immun 23JUL91 & had SIDS on 25JUL91;
Woke up the day following vaccination with bad headache, nausea (but no vomiting), fatigue, aches/pain all over.  Symptoms slowly faded over Sat/Sun (30/31 July) and were pretty much over by end of 8/1.
Small patch of shingles on right butt cheek; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 11Apr2021 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) for unknown indication, from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 21Mar2021 at 12:00 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. On 13Apr2021 at 01:00, the patient experienced small patch of shingles on right butt cheek. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event small patch of shingles on right butt cheek was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
My arm, my shoulder was sore but I think about gone by now; My arm, my shoulder was sore but I think about gone by now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for COVID-19 immunization; Bnt162b2 (second dose), administration date: Mar2021, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Oct2021, outcome "recovered" (Oct2021) and all described as "My arm, my shoulder was sore but I think about gone by now". Additional information: The patient stated that he got his third shot, booster yesterday and now he was not having a reaction, his arm, his shoulder was sore and stated that he thought about gone by now but that was no reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT EXPERIENCED VERTIGO BUT HAS HISTORY OF VERTIGO. PATIENT WATCHED AN ADDITIONAL 5 MINS AND THEN PATIENT STATES FEELS BETTER AND WANTS TO LEAVE. PATIENT INSTRUCTED TO FOLLOW-UP WITH EMERGERNCY DEPARTMENT IF HAS ANY NEEDS. PATIENTS HEART RATE IS 70 AND REGULAR AT TIME SHE LEFT.
10/22/2021 woke up at 10am I had a rash around my lips, it is still there, but it is much better than it was.
Patient reported an extreme burning sensation at time of injection. She described it as like "lightening", both electrical and heat that radiated from the injection site to her fingertips.  Pain started with administration of vaccine.  She felt "crumby" on Saturday.  Today she no longer feels the burning sensation, but has a 1/2" ring around injection site that is swollen and bruised. She also reported feeling a knot under her skin.  She did not seek medical attention and was quite embarrassed that she cried after her injection.
2-3-06 general malaise to lightheadedness, violent chills, fever, achy body, loose stools, headache; 2-4-06 same with reduced chills; 2-5-06 same no chills; 2-6-06 better, no fever, loose stools remain; 2-6-06 self treatment: Ibuprofen, fluids, bed rest. Activity as to violent.
After taking a shower in the morning I was combing and brushing my hair and blow drying it due to the cold weather. When brushing my hair I clumps of it started falling out at the roots around my face and at the scalp. It has been continuing to fall out ever since the 21st of December. My hair also feels extremely dry like straw especially the bangs. My hair used to feel like cornsilk, however now it is completely dried out and my hair cannot be styled. It is still falling out.
low Liver function; light tan poop; Swollen Legs and feet; Swollen Legs and feet; 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 HEPATIC FUNCTION ABNORMAL (low Liver function), FAECES DISCOLOURED (light tan poop), the first episode of PERIPHERAL SWELLING (Swollen Legs and feet) and the second episode of PERIPHERAL SWELLING (Swollen Legs and feet) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEPATIC FUNCTION ABNORMAL (low Liver function), FAECES DISCOLOURED (light tan poop), the first episode of PERIPHERAL SWELLING (Swollen Legs and feet) and the second episode of PERIPHERAL SWELLING (Swollen Legs and feet). At the time of the report, HEPATIC FUNCTION ABNORMAL (low Liver function), FAECES DISCOLOURED (light tan poop) and the last episode of PERIPHERAL SWELLING (Swollen Legs and feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.  Company comment: Very limited information regarding these events has been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected.
This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 67-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8727), dose 2 via an unspecified route of administration, administered in Arm Left on 23Mar2021 (At the age of 67 years) as DOSE 2, SINGLE for covid-19 immunization. Medical history included anxiety (Verbatim: Anxiety), dyspepsia, stress from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included Flu shot for immunization leading to pain on unspecified date. Patient also had bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ENU205), dose 1 via an unspecified route of administration, administered on (At the age of 67 years) 02Mar2021 as DOSE 1, SINGLE for covid-19 immunization. On 23Mar2021 the patient experienced arm had been start hurting, shoulder has been start hurting it was very painful, patient cannot turn his arm and could not try to move the arm if need to move; it moves a little bit sometimes and had like a little lump and on unspecified date of 2021 patient had kind of give like spasm and twitches. Patient did not get any treatment for adverse events. The patient underwent lab tests and procedures which included x-ray and had everything came out okay on unspecified date of 2021. The outcome of the event like a little lump, kind of give like spasm and twitches was unknown, while the outcome of the rest of the events was not recovered.No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a healthcare worker refers to a 12 year old patient of unknown gender. On 13-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot # K011562, expiration date 08-APR-2017) (strength, dose and route were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Woke up and noticed itchy spots on arms and swollen face and ears; applied topical Benadryl; later on noticed rashes to neck, face, upper back, knees, arms/elbows.
Today employee awoke and noted rash to right upper arm where vaccine was applied on 9-18-08.  Employee indicated area he noted rash at site where vaccine was placed he did experience some itching.  He called occupational health nurse separating reaction and rash to right upper arm, reaction noted on VAERS form.  Tx: Benadryl and Antibiotic ointment to site.
Started with chest oppression and increased heart rate of 105 which comes and goes .  Next day I started feeling very lightheaded and very dizzy.  I had to sit out in the fresh air as to avoid fainting.  It has not left me since, I am dizzy and lightheaded most of the time, sometimes in the verge of fainting. The second day my jaw locked for a few seconds.  A couple of days after I started to feel needles and pins in the left part of my body mainly, not always, but mainly.  My right hand started hurting one day and could hardly write but that sorted itself out.  Now my left little hand finger gets sort of paralyzed and still has not cleared.  I cannot push the cart in the supermarket because my breathing seems to collapse and I have to constantly stop and start over really slow. I have mild headaches, mild, they are not strong.  I nearly lost balance at work one day and I have to move around really slow as to not have to go outside and sit in the fresh air.
Slight low grade fever; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight low grade fever), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Slight low grade fever), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 18-Jan-2021, PYREXIA (Slight low grade fever), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Headache Swelling at the vaccine site last night, but hetting better today; today developed headache Narrative:
This spontaneous report as received from a pharmacist refers to a 35 year old male patient. On 09-DEC-2011, the patient was vaccinated with his first dose of GARDASIL, .5 ml, intramuscular and experienced inappropriate age of vaccination. On 16-JAN-2012 the patient was vaccinated with his second dose of GARDASIL, .5 ml, intramuscular. About one month later, the patient experienced warts on his hands. The patient received treatment including "freezing lesions off and prescribing ALDARA." The patient declined to receive the third dose of GARDASIL. The outcome of warts and inappropriate age of vaccination is unknown. Additional information has been requested.
01/03/2022 pain started and by 01/06/2022 I broken out in shingles. I'm still feeling the after effects of the shingles. On 01/10/2022 I was diagnosed with it by PCP. The days I was hurting before shingles broke out, a rash had showed up in the spots I was hurting.