chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt miserable; Slight sinus congestion; Slight minimal productive cough; Inflammation at local site; Fever; Achiness; Headache; Localized soreness in the arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MALAISE (Felt miserable), SINUS CONGESTION (Slight sinus congestion), PRODUCTIVE COUGH (Slight minimal productive cough), INJECTION SITE INFLAMMATION (Inflammation at local site) and PYREXIA (Fever) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced MALAISE (Felt miserable), SINUS CONGESTION (Slight sinus congestion), PRODUCTIVE COUGH (Slight minimal productive cough), INJECTION SITE INFLAMMATION (Inflammation at local site), PYREXIA (Fever), MYALGIA (Achiness), HEADACHE (Headache) and INJECTION SITE PAIN (Localized soreness in the arm). On 12-Jan-2021, INJECTION SITE INFLAMMATION (Inflammation at local site) had resolved. On 13-Jan-2021, MALAISE (Felt miserable) had resolved. On 15-Jan-2021, SINUS CONGESTION (Slight sinus congestion), PRODUCTIVE COUGH (Slight minimal productive cough), PYREXIA (Fever), MYALGIA (Achiness), HEADACHE (Headache) and INJECTION SITE PAIN (Localized soreness in the arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 99.8 °F. On 13-Jan-2021, Body temperature: 100.4 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Swollen at the injection site. Lumpy/ bump. A bubble form immediately following injection. Warm to the touch. Tender and painful. Fatigue. Headache. Body aches.
This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 35-year-old female patient who received HBV (Engerix B adult) (batch number F73DG, expiry date 3rd July 2023) for prophylaxis. Previously administered products included Engerix B (1st, 2nd and 3rd dose received on an unknown date). On 6th January 2022, the patient received the 4th dose of Engerix B adult. On 6th January 2022, unknown after receiving Engerix B adult, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that his colleague received an Engerix-B 4th adult dose by error, which led to extra dose administered. The reporter did not consent to follow-up.
Pt presented to COVID vaccine clinic today and developed a reaction after receiving the vaccination. Pt received the Moderna vaccine.    Denies allergies or hx of anaphylaxis.    Pt reported immediate flushing sensation, tingling of the tongue, and dizziness after receiving vaccination. Pt was slightly diaphoretic.  VS immediately following vaccination:  HR: 90 O2: 100% BP: 125/74  Pt denied SOB, difficulty swallowing, chest tightness, nausea, rash, itchiness at this time. No visible swelling.    Flushing, tongue tingling, and dizziness started to resolve after laying down for 15 minutes but then quickly returned and worsened. Pt also then developed nausea, ?tongue thickness?, difficulty breathing, and tingling shooting down her arms and legs.  HR: 87 O2: 99% 129/77 Code Blue called.  Epi Pen injector (one dose) administered at 0951.  ED code team arrived and transported patient to ED for further workup and observation.  Paged Allergy
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Oct2022 as dose 5 (booster), single (Lot number: CH9697) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 16Apr2021 as dose 2, single (Lot number: ER8732), in left arm, on 10Nov2021 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 02Jul2022 as dose 4 (booster), single (Lot number: FM7553) for covid-19 immunisation. The patient's relevant medical history included: "Pollen allergies" (unspecified if ongoing), notes: Pollen allergies; "allergic to yellow jackets" (unspecified if ongoing), notes: previously allergic to yellow jackets but also took shots and became desensitized. The patient's concomitant medications were not reported. Past drug history included: Immunotherapy injections, notes: Patient took immunotherapy injections prior to pandemic. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: virtually negative; (Mar2023) Positive, notes: intensely positive; (Mar2023) Positive, notes: test positive 5 days after relapse. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: During 5- day course of Paxlovid, symptoms decreased, and tests became virtually negative. Approximately 3 days after last dose, nose started to run excessively, tests returned intensely positive results. Congestion and malaise returned. Seem to be getting better but continuing to test positive 5 days after relapse.
Initial report received from non-healthcare professional (Attorney) on 21 May 2013. The male patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE intradermal (batch number and dose number were not reported) intradermally in upper left arm on 26 January 2013. It was reported that on an unspecified date, after receiving Influenza vaccine, the patient experienced scar.  The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not reported. Documents held by sender: none.
Approx. 3 hours after the shot, I began feeling a squeezing sensation in my throat, my chest burned and I kept coughing a lot.  I thought I had a sudden onset of a cold, but with no other symptoms.  Then I started getting hoarse, and developed hives on the inside of my mouth.  I lost my voice for a short period of time as well, but after receiving benadryl, all the symptoms cleared up.  I am supposed to take it every 6 hours for 3 days, and when the time is getting close for the next dose, I start to wheeze and cough again.
This spontaneous report was received from a physician assistant and refers to a 44 year old patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 29-NOV-2017, the patient was vaccinated with PROQUAD, therapy type rHA, lot # M044575, expiration date 04-MAY-2018, for prophylaxis (dose and route of administration were not provided). Concomitant therapies included sterile diluent. The administered dose of PROQUAD was stored in the refrigerator from 18-OCT-2017, in temperature of 39 degrees Fahrenheit for 1008 hours (42 days). The call was because of digital data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1712USA014367: US-009507513-1712USA014360: US-009507513-1712USA014361: US-009507513-1712USA014362: US-009507513-1712USA014363: US-009507513-1712USA014364: US-009507513-1712USA014365: US-009507513-1712USA014366.
carpal tunnel syndrome in left wrist; Pain in shoulders / pain is more severe in the left shoulder; pain in the groan; loss of range of motion in arms; trouble walking; constipation; diarrhea; dehydrated; He is sensitive to hot and cold; trouble sleeping due to all the pain; pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of carpal tunnel syndrome in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes, carpal tunnel syndrome (on right wrist for tunnel syndrome), cervical disc herniation and back injury.   On 18th December 2020, the patient received the 1st dose of Shingrix. In December 2020, 1 week after receiving Shingrix, the patient experienced carpal tunnel syndrome, shoulder pain, groin pain, mobility decreased, walking difficulty, constipation, diarrhea, dehydration, injection site pain, temperature intolerance and difficulty sleeping. The patient was treated with paracetamol (Tylenol), ibuprofen, tramadol and hydrocodone. On an unknown date, the outcome of the carpal tunnel syndrome, shoulder pain, groin pain, mobility decreased, constipation, diarrhea, dehydration, temperature intolerance and difficulty sleeping were not recovered/not resolved and the outcome of the walking difficulty was unknown and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the carpal tunnel syndrome, shoulder pain, groin pain, mobility decreased, walking difficulty, constipation, diarrhea, dehydration, injection site pain, temperature intolerance and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient had his first dose and had pain at the injection site that lasted a week.  The rest of the symptoms began to appear approximately a week following the shot. Pain in shoulders and pain in groin area presented. The pain was more severe in the left shoulder which was the injection arm. The pain in the groin was noticed when he had trouble walking because of it. He had loss of range of motion in arms due to the shoulder pain. He had been experiencing constipation, diarrhea and had dehydrated. The patient was sensitive to hot and cold and gets overheated easily with a blanket. He was diagnosed with carpal tunnel syndrome in his left wrist and has trouble sleeping due to all the pain. He was taking Tylenol, Ibuprofen, Tramadol and Hydrocodone to manage the pain. The reporter consented to follow up.
Patient came to pharmacy today expressing concern about left arm pain at the injection site of immunization received in August. She claims that the "sharp, shooting pain" comes and goes, but never completely went away after receiving SHINGRIX.
I had a low grade fever and muscle aches. I also have ongoing hip pain since getting my previous Covid vaccines. I am still taking the gabapentin for my hip pain.
Torso: Pain/Discomfort across front of chest (about 2 inches above nipple) ? started on left   side but also presented on the right too. Pain/Discomfort in back on both sides.  Sometimes upper back, sometimes lower. Pain/Discomfort and sometimes a burning sensation in ribs.  Many times this  presented itself at the lower tips of the ribs. Arms: Pain/Discomfort under armpits. Tingling in arms.  There was a point where my arms would fall asleep when I was  laying down at night. General weakness/fatigue in the arm. Sometimes arms (particularly the forearms) feel tight   Leg Pain/Discomfort in calves.  Many times, the pain would be a sharp, pointed  sensation in both calves.  This discomfort always presents itself in the back of my calves.        *Weakness/Fatigue in thighs.  Many times my thighs will feel weak/fatigued.  Neck: Pain/Discomfort in my neck.  Primarily this occurs on the sides of my neck.  There is also a tightness that occurs on the sides of my neck too. At times, the back of my neck is also tight and uncomfortable.  Spine: General tightness and discomfort running down the middle of my back.  This  occurs primarily in the upper to middle part of my back.  Overall: Along with the different sensations listed, I have battled constant fatigue and a feeling of weakness.  This weakness could be overall throughout the body or sometimes just in certain regions in my body.  For example, some days I might feel like my arms are weak/fatigued, other days it might be my legs, and then sometimes throughout my body.  I have also been dealing with persistent headaches from time to time.
received a vial that was punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vial that was punctured more than 12 hours ago) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vial that was punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vial that was punctured more than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was provided by the reporter. No treatment information was provided by the reporter. No Concomitant medicines were reported.
12/17/2020 VACCINE 12/18/2020 SWOLLEN LYMPHNODES IN GROIN, FATIGUE  12/21/2020  EXPERIENCED A STEMI; RUSHED TO ER; FELT LIKE COULDN'T BREATHE, INCREASED HR CARDIAC CATH
Patient received Moderna COVID vaccine on 1/20/21 (lot # 011L20A), 2/24/21 (lot # 002A21A), and 12/16/21 (lot # 069H21A). On 5/12/22, patient admitted to our inpatient facility with COVID-19 pneumonia, acute respiratory failure with hypoxia, and advanced Alzheirmer's dementia. He was discharged on 5/18/22 back to his assisted living facility.
Received vaccine 10/13/2015 8:55 AM. At time of administration no pain but then noted pain that increased within 3 hrs and site swelling noted. More swelling as day progressed. 10/14/2015 9:05 AM went to walk in medical clinic. No testing. Visual assessment made by MD of cellulitis and abscess right arm bicep to fingers. Treatment: Prednisone 50mg QD x 5 days - started 10/15/2015 - 10AM. Cephalexin 500mg PO QID x 7 days - started 10/15/2015 8PM.
Patient developed fever, myalgia, headache, chills, joint pain, and pain behind the eye following recent travel and 20 days post second dose of Moderna vaccine. Troponin of 0.44/high Troponin 507.94. Patient was managed for a broad differential includign Myocarditis (viral vs. COVID vaccine) and received Vancomycin, Unasyn, Doxycycline, Ibuprofen and colchicine. Patient currently stable and discharged after 3 days of admission.
Like a lot of people, I had a headache, nausea, and extreme fatigue, but I my extreme fatigue lasted twelve days.  It is now fifteen days later.  I still get headaches, I am still tired (but able to work), and I am still so weak that I have trouble opening jars.
Information has been received from a registered nurse referring to a female patient of unknown age. There was no medical history or drug reaction/allergies reported. In 2014, the patient received her first dose of ZOSTAVAX (dose, route and lot # were unknown). On 14-SEP-2015, the patient was inadvertently administered a second dose of ZOSTAVAX (dose, route and lot# were unknown) (extra dose administered, medication error). No concomitant medication was provided. No adverse effects reported. Additional information has been requested.
It was reported that a patient (1 of 5) received a rabies vaccination on 5-Mar-2001. reportedly the patient developed a headache, sore muscles, nightmare, insomnia and a local reaction lasting 2-7 days. Further information is requested.  From telephone conversation on 6-Apr-2001, it was reported that the patient recovered from the experience.  From additional correspondence received on 18-APR-2001, the correct vasccination date (5-Mar-2001) was provided. additional patient, vaccine, responsible physician and vaccine administrator information was also provided. This case is closed.
2nd dose of Pfizer 0.2ml vaccine was administered to the patient on 11/28/21. After receiving the vaccination patient fainted. The patient was assessed and monitored by the site lead and nursing staff for one hour. The patient was reassessed, found to be functioning appropriately, then released to the family per the Mother's approval.
Information has been received from a physician, for GARDASIL, a Pregnancy Registry Product, concerning a 17 year old female patient with no concomitant medication, no pertinent medical history and no drug reactions or allergies, who was vaccinated with the first and second dose of GARDASIL , 0.5ml, IM., (lot number not reported) on 29-SEP-2012 and 13-JAN-2012, respectively and was pregnant. The patient sought medical attention. Pregnancy test was performed, The patient last menstrual period was an approximately on 03-SEP-2011 (also reported as "4 to 5 months"). Estimated delivery date is an approximately on 09-Jun-2012. Follow-up information was received from the physician who stated that the patient's last menstrual period was on 03-SEP-2011 and estimated delivery date was 09-JUN-2012. On an unknown date, the patient developed pregnancy induced hypertension (PIH). The physician reported that on 22-JUN-2012 (reported as 39 weeks from LMP), the patient delivered a female baby, weight 3445g, length 53cm, Apgar score 9/9. It was reported that the infant was normal and also that the baby was diagnosed with bilateral preauricular sinus (date unspecified). At the time of the report, the patient's outcome was unknown. The infant adverse event was captured in MARRS# 1207USA008497. Additional information has been requested.
Pt recve MMR/Td on 16APR92 & on 28APR92 devel fever, rash ont runk & extremities & joint pains, t103 lasting 5-6 days;
Improperly stored dose of gardasil 9 was administered to the patient; No adverse effect; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on medical history, concurrent condition, concomitant medications and drug reactions/ allergies were unknown.  On an unknown date, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N022952 and expiry date 14-JUN-2020 (strength, frequency, dose, route, anatomical location were not reported) for prophylaxis. The suspect vaccines experienced the temperature excursion below 36-degree Fahrenheit (F) (32.1 F) for 8 hours. It was reported that no previous temperature excursion was done. Data logger was involved. There was no adverse effects reported. No product quality compliant reported in the case.
Localized rash to bilateral upper arms, non infected, non erythematous, did not worsen over the course of 1 month time period. Non systemic.
48 hours post vax, the pt developed cervical adenitis with fever. Treated with IV Clindamycin and Doxycycline for 48 hours. Then treated with Clindamycin by mouth for 7 days.
When I woke up Friday, my arm was a bit sore, but not too bad, and there are a small red bump, like a mosquito bite.  During the day Friday I started getting a slight headache, but 3:30 I started to get fatigued and I drove home from CDC.  When I got home, it got worse, started getting a bit of a fever and mild chills by 5:30pm.  I stayed in bed and rested the rest of the evening, I feel like the fever broke about 10pm, but stayed hot throughout the night.  Saturday morning, I woke up feeling better, like the day after being sick.  Today I am back to 100%.  The injection site is swollen a bit and red, maybe 3"X5" in size.  It is still warm to the touch.
Information has been received from a licensed practical nurse concerning a 39 month old male with OMNICEF allergies who was vaccinated with the first and second (lot # 662201/1544X) dose of VARIVAX (Merck), SQ, 0.5ml on 14-JUN-2006 and 30-MAR-2009 respectively.  Concomitant therapy included DTAP on the left thigh, inactivated poliovirus vaccine on the right thigh.  On 02-APR-2009 the patient experienced red, warm and swollen in left thigh that looked like cellulitis.  The patient was treated with BENADRYL, BACTRIM and KEFLEX.  The patient had no lab diagnostics studies performed.  The physician saw the patient.  At the time of the report the patient was recovered.  Follow up information has been received from the licensed practical nurse concerning the patient with no illness at time of vaccination who received the second dose of VARIVAX (Merck) in left thigh on 30-MAR-2009 at 2:30 PM.  Subsequently the patient experienced cellulitis in left thigh, it was swollen, red and warm.  The patient was placed on KEFLEX and warm compress.  The event required emergency room/doctor visit.  At the time of the report the patient was recovered.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the Center of Biologics Evaluation and Research and was released.  No further information is available.
Stomach pain; Neck pain; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ew0162), via an unspecified route of administration in the left arm on 12Apr2021 at 14:45 (at the age of 44-years-old) as single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. Concomitant medication included paracetamol (TYLENOL) from an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. On 12Apr021 at 15:00, the patient experienced stomach pain and neck pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of stomach pain and neck pain were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
woke up early weds morning, with room spinning.  crawled to the bathroom, and vomited.  missed work as spent day in dark room, hard to move my head.   no more 'vertigo' affects, but left with continuous 'foggy head' and fatigue
Received 1st shot, experienced headache, dizziness, fatigue, dry mouth, and knee joint pain in my left knee. Headache, Dizziness, fatigue, and dry mouth went away after a couple days but knee joint pain persists. It is now painful to place my weight on my left knee. Received 2nd dose today also mild headache, experienced shakiness and loss of balance, and dry mouth but expecting those symptoms to subside after a few days. Knee pain persists.
3 hours after shot: headache, dizziness, nausea, fatigue. Next morning: soreness at site of shot, headache, slight light-headedness, fatigue.