chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very tired; did not feel like doing anything for a day afterwards; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (did not feel like doing anything for a day afterwards) and FATIGUE (very tired) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (did not feel like doing anything for a day afterwards) and FATIGUE (very tired). At the time of the report, FEELING ABNORMAL (did not feel like doing anything for a day afterwards) had resolved and FATIGUE (very tired) outcome was unknown. No concomitant medications were reported.  The patient received first booster dose at the end of April 2022 or early May 2022. The lot number and expiration date were not available.  No treatment medications were reported.   This case was linked to MOD-2022-569656, MOD-2022-569659 (Patient Link).
This spontaneous report as received from a nurse refers to a 13 years old female patient. No medical history of concomitant conditions were reported. It was reported that the patient had no known allergies. The nurse reported that the patient received the first dose of GARDASIL on 12-JUN-2012 (lot number reported as 1016Z with an expiration date of 22-NOV-2012). The second dose was received on 17-AUG-2012 (lot number reported as 1016Z with an expiration date of 22-NOV-2012). The route of administration and anatomical location were not reported. No co-suspects or concomitant medications were reported. The patient developed fatigue with whole body pain, but mostly abdominal and back pain on 24-SEP-2012. About a week later the patient experienced a headache with worsening of the pain (whole body pain but mostly abdominal and back pain) and a burning sensation (discomfort) in the chest. Fatigue was reported as a significant disability or incapacity because the patient was unable to attend school for the last month due to fatigue. The patient was evaluated for a urinary tract infection and Rocky Mountain Spotted Fever. No results were provided. The patient had an emergency room visit in the first week of October which was pain related. No treatment information was provided and the patient did not recover from the events. The reporter relatedness for fatigue, burning sensation (discomfort) in the chest, headache, whole body pain but mostly abdominal and back pain is unknown for GARDASIL. No further information was provided. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 at 09:00 as dose 1, single (Lot number: EN2606), in left arm, on 27May2021 as dose 2, single (Lot number: ER2613), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 05May2022 as dose 4 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Coeliac disease" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM+D3; LYSINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken because of vaccination failure, covid-19 with paxlovid started on 05Jul2022 treatment stop date=09Jul2022.  Clinical course: Adverse event: None. Sore arm per usual. Patient was writing to say that patient have Paxlovid rebound and patient very disappointed to have another long quarantine. Please let others know this can happen. patient wouldn't have taken the drug if patient had known this earlier. Other medication in 2weeks product included Multivitamin, Calcium+D3, LLysine  No follow-up attempts are possible. No further information is expected.
The vaccine was administered after a previous dose of Pfizer 4 days apart.   Patient was brought to receive the vaccine at two different sites by two different caregivers. Called the patient on 2/10/21 and 2/12/21 and patient was not experiencing any adverse reactions. Notified son who is the primary guardian to report any adverse reactions and that a follow-up dose of either vaccine was not recommended by CDC guidelines.
I'm currently breastfeeding.  I noticed my milk supply seemed to drop following vaccination. It's been almost two months and I'm finally starting to be back on track with what I was able to pump prior to the shot. Lots of water and lactation cookies later...
1 hr. ago had seasonal/H1N1 vaccination. Noted itching at site right away - removed band aid. Noted within 30 min., itchy ankles. 1/2 hr. later roof of mouth. Site warm, red to touch - presented to clinic. BP 166/102, P 88, R 16. Lungs clear, T 98.2. Repeat BP 138/102. BENADRYL 11:15 AM 50mg NDC 0904-2056-61, expire 5/1/2011. TC 10/8/10 with pt. Did well, feeling ok. BP 141/81 today. Advised f/u with her MD for BP and evaluation/recommendation for future flu vaccination.
Severe chills and fever upto 103 f, body ache and head ache on first day, took acetaminophen 250mg 2tabs at night,  continued chills and fever of 100f on 2nd and 3rd day with sever body and muscle ache, head ache. 4th day no fever but sever body and muscle ache, head ache. Had fatigue and headache continue for 2 weeks after that.
Low grade fever; Nausea; Chills; Arm sore; This is a spontaneous report from a contactable consumer (Patient). A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 09Feb2021 at 16:45 (at the age of 43-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. Patient had no known allergies. Concomitant medication(s) included valacyclovir [valaciclovir] (VALACYCLOVIR [VALACICLOVIR]) taken for an unspecified indication, start and stop date were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 10Feb2021 (at 12:00AM, as reported), the patient experienced Low grade fever, Nausea, Chills, Arm sore. Patient did not received treatment for adverse events. Outcome of the events were not recovered.       Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Onset of maculopapular, pruritic rash, primarily on upper chest, lesser so on abd and arms, 3 hrs after receiving vaccine papules were with tiny vesicles initially.
2/16/11 cough & runny nose started, no fever, pt. was vaccinated 10/12/10 for influenza tender, cervical lymph nodes. (+) rapid flu in clinic, PCR sent to state lab.
68 y.o. male reportedly with a PMH significant for HTN, ESRD (RUE fistula) and a history of ACE inhibitor induced angioedema (no longer on ACE inhibitors, clearly).  Has had some milder angioedema presentations since stopping ACE-I.  Is scheduled for an angiogram next week (wife says its for pulmonary hypertension, but then mentions possibly placing stents).    On 1/8/2022 early AM his wife woke up and noted patient had severe tongue swelling, EMS was summoned and he presented to the ED. Tongue was markedly engorged. He was intubated for airway obstruction. Has received diphenhydramine and epinephrine.    Has been hypertensive since arrival.    He is being admitted to the ICU under the care of the critical care medicine service. DISCHARGE DIAGNOSES:   Clinical Indicators Treatment Response to Treatment   Acute angioedema with severe tongue swelling, resolved Acute airway obstruction due to the above, resolved Acute hypoxic respiratory failure due to the above, resolved Incidental COVID-positive without COVID-pneumonia, improving Elevated dimer due to the above, suspect improving   Patient was admitted to the hospital with significant swelling of his tongue suspected to be angioedema consistent with prior presentations. No clear trigger. Intubated and remained intubated for several days in the intensive care unit. Given steroids, H2 blockers, H1 blocker, epinephrine. Patient had slow improvement and was able to be weaned down on his ventilator needs over time. He was successfully extubated and had complete resolution of swelling of his tongue and airway obstruction prior to discharge. Voice normal. Functioning at his baseline activities of daily living prior to discharge. Discharged on a steroid taper and famotidine. The patient was found to be incidental COVID-positive but never required supplemental oxygen. Vital signs were monitored and the patient was stable regarding his respiratory status. Do not suspect symptomatic COVID. Discharge recommendations given regarding quarantine and so forth The patient responded well to the monitoring and treatment as described, and will follow-up with their primary provider as an outpatient.       Chronic hypertension Chronic renal failure, end-stage renal disease on dialysis Chronic anemia of chronic disease The above listed chronic medical conditions were monitored with routine vital signs, physical examinations, and appropriate laboratory testing and were deemed to be without exacerbation during this hospitalization.  The patient was continued on their home medication regimen for these problems and they responded well to this treatment.
A non-serious spontaneous report of "administration of expired product" was received from a health professional concerning a 30-month-old female subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. On 02-Mar-2010, expired FLUMIST was given. The product expired in 17-Feb-2010. There was no adverse event associated with this medication error as of 17-Mar-2010; therefore, treatment and reporter/sponsor causality assessment are not applicable, and the event is considered resolved. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
High fever of 102-103, chills, whole body aches lasting three days, shortness of breath
red splotches on tongue and bumps around edge of tongue day after injection; mild-moderate headache; moderate tiredness; Dizziness the first 30 minutes; swollen lymph nodes starting 1-2 hours after injection, lasting approx. 6 hours; red splotches on tongue and bumps around edge of tongue day after injection; This is a spontaneous report from a contactable consumer, the patient.  A 74-year-old patient of unknown gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1284), via an unspecified route of administration in the right arm on 02Jan2021 at 11:00 (at the age of 74-years-old) as a single dose for COVID-19 vaccination.  Medical history included fibromyalgia, bronchiectasis, Degen. Scoliosis, spinal stenosis, peptic esophogitus grade II, osteoarthritis and benign nodules in both upper lobes of lungs (Pulmonary scarring-bilateral lower lobes). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had allergies (unspecified) to medications, food, or other products. The patient's concomitant medications were not reported; however it was reported the patient did receive other medications (unspecified) within 2 weeks of the vaccination.  The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  The patient experienced dizziness the first 30 minutes on 02Jan2021; swollen lymph nodes starting 1-2 hours after injection, lasting approx. 6 hours on 02Jan2021; red splotches on tongue on 02Jan2021 and bumps around edge of tongue day after injection on 03Jan2021; mild-moderate headache on 02Jan2021 and on 02Jan2021 moderate tiredness lasting 2 days+. The patient did not receive any treatment for the events. The clinical outcome of the dizziness the first 30 minutes, swollen lymph nodes starting 1-2 hours after injection, lasting approx. 6 hours, red splotches on tongue and bumps around edge of tongue day after injection, mild-moderate headache and moderate tiredness was recovering.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Patient reported having a rash/itching hands and feet about 2days after the vaccine. Took Benadryl 4 times a day and resolved two days later. was told to contact primary care physician before getting the second dose
Information has been received from a nurse practitioner concerning a 5 month old female with no pertinent medical history or drug allergies who on 02-AUG-2007 and 26-OCT-2007 was vaccinated PO with her first and second doses of RotaTeq vaccine (lot# 657045/1053U). There was no concomitant medication. On approximately 26-OCT-2007, the patient  experienced abdominal pain. On 26-OCT-2007 (Friday), the patient experienced diarrhea and vomiting for the next  two days (Saturday and Sunday). The patient was still experiencing abdominal pain. Unspecified medical attention was sought. No labs or diagnostic studies were performed. The outcome was not recovered. It was noted that the patient did not have the same adverse experience after the first dose. There was no product quality complaint. Additional information has been requested.
On June 26th, I woke up and my calf felt like I had a charley horse in it all night long. I could feel a knot in my calf. I thought I could walk it out so I walked 10 miles that day. It didn't go away. Monday morning, I woke up and I could still feel the knot. I went to urgent care. He said he couldn't evaluate me because he didn't have an ultrasound. I was sent to the ER. They did an ultrasound of my leg. They said all my veins were clear. I was bitten by something on the Wednesday before and told them about it. I went home and elevated and iced it. Tuesday and Wednesday, I took it easy. Wednesday night, I noticed my lower leg and ankle were swollen. On the 29th, I had a lot of swelling in my lower ankle. I went back to the ER and they did anther ultrasound. Everything still looked good. Friday morning, I went to see my PCP. She wanted to refer me to a vascular person. I got home and my daughter suggested I test for COVID-19. I took a COVID-19 test and it was positive. I've had no other symptoms.
Patient is fully vaccinated as on 03/04/2021 with Pfizer and contracted COVID, tested positive on 9/17/2021
Racing/pounding heart; short of breath; nasuea; fever; diarehea; dizziness; headache; chills; body aches; weakess; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Sep2021 12:00 (Lot number: fd8448) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Had Covid Nov 2020", start date: Nov2020 (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: LEVOTHYROXINE and multi vitamin. The following information was reported: PALPITATIONS (non-serious) with onset 05Sep2021, outcome "not recovered", described as "Racing/pounding heart"; DYSPNOEA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "short of breath"; NAUSEA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "nasuea"; PYREXIA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "fever"; DIARRHOEA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "diarehea"; DIZZINESS (non-serious) with onset 05Sep2021, outcome "not recovered", described as "dizziness"; HEADACHE (non-serious) with onset 05Sep2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 05Sep2021, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 05Sep2021, outcome "not recovered", described as "body aches"; ASTHENIA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "weakess". The events "racing/pounding heart", "short of breath", "nasuea", "fever", "diarehea", "dizziness", "headache", "chills", "body aches" and "weakess" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of palpitations, dyspnoea, nausea, pyrexia, diarrhoea, dizziness, headache, chills, pain, asthenia.  No follow-up attempts are possible. No further information is expected.
10/30/09 rash and 103 degree temp PM, approximately 7:00 PM. Call to ER. Instructed to give child BENADRYL and TYLENOL by ED physician. Mother reported rash lasted approximately 3 hrs. 11-2-09 office visit at PCP office. Dx with flu. Prescribed TAMIFLU.
Case number PHEH2016US029294, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 68 years old male patient. Past medical history and concomitant medications were not reported. The nurse stated that first temperature excursion of FLUCELVAX Quadrivalent at 52F for 1 hour occurred on 18 Oct 2016. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml intramuscularly on 20 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34F and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2F three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
VACCINE ADMINISTERED 6 DAYS PAST THE BEYOND USE DATE OF 6/30/2022. POTENTIAL FOR LACK OF EFFICACY.
Subsequently the pt experienced cellulitis characterized by a red, raised, sore, hot area at the injection site on the right arm. It was also noted that the pt spiked a fever. Unspecified medical attention was sought and the pt was placed on antibiotic therapy and "he got better". Additional information has been requested.
2 hours after the vaccine  I began to have shakes and my body temperature was 102,  normal fever for a vaccine so I wasn?t worried I made some mint and ginger tea and laid down. Soon after I started having slight breathing difficulties,  like I was having an asthma attack, Around 5-6 hours after taking the vaccine on Monday night my right eye just started hurting and burning, a couple hours later when I looked in the mirror it was big so I was a little worried, woke up the next day and my right eye was even bigger and my vision was blurry and it hurt a lot. I went to work wore a sunglasses the whole day as I couldn?t open my eye or look into  any types of light, sunlight,  LED all those hurt and made my eyes water nonstop. The next day I woke up to go to work and couldn?t see out of my right eye at all. I tried to cover my left eye to see in my right eye and I saw nothing.  I started worrying and asked my father if I should go to the hospital because I cannot see out of my right eye and he told me it was an allergic reaction to the vaccine if it gets worse to see a doctor.  Last day was Friday the swelling in my eye started going down but my vision was still blurry and it watered a lot.  so I was preparing to go to the hospital on Saturday which is my day off.  I woke up on Saturday morning and my eye shrink significantly and I upgraded to blurry vision again so I felt a little more comfortable seeing the progress but it was the scariest thing in my life as I thought I was losing my sight. Has that ever happen to anyone? Will it happen on my next dose? How do we prevent this from happening?
A report has been received from a Health Professional concerning a Male subject who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 milliliters, Once/Single administration. FLUMIST Quadrivalent (Intranasal) started during 2014. HCP reports that patient under 9 only received 1 dose of FLUMIST in 2014 flu season. FLUMIST Quadrivalent (Intranasal) was continued. The patient recovered from the event patient under 9 only received 1 dose of FLUMIST in 2014 flu season during 2014. The report was considered to be non-serious.
I received my booster shot on 1/20. I immediately started having an adverse reaction. Within hours I couldn't move my arm what so ever and I could feel debilitating pain radiating up the left side of my neck and down my finger tips. I couldn't move my neck to the left of my left wrist at all. I then began having nerve pain in my feet, severe headaches and dizziness, high fevers, excruciating joint pain, and vomiting.  For approximately one week after I felt off balance and dizzy.
upper right lip swelling; hive on forearm above elbow on left arm; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), intramuscular in the left arm on 05Jan2021 15:00 at a single dose for COVID-19 immunization. The patient's medical history included type 2 diabetes. The patient had no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included metformin and glucosamine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 06Jan2021 17:00, the patient experienced hive on forearm above elbow on left arm then on 07Jan2021, the patient experienced upper right lip swelling. No treatment was received for the adverse events. Outcome of the events was unknown. The events were considered non-serious by the reporter.
This spontaneous report as received from a pharmacist refers to a currently 72 years old male patient with no drug reactions/allergies. Patient's medical history and concurrent condition were not reported. On 25-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # K023621, expiry date: 19-FEB-2016), 0.65 ml, subcutaneous for prevention of shingles. Concomitant therapies included OXYCODONE. Subsequently, on an unknown date in 2015 (reported as "last couple of days"), the patient experienced itchy, painful, bumpy rash on both arms and both legs. The outcome of the events was not reported. The patient sought medical attention - family member called the pharmacist. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.