chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sleeps seven hours, but now he is sleeping between nine and ten hours; In bed for two days; Sore; fatigue; Muscle soreness; This spontaneous case was reported by a health care professional and describes the occurrence of SLEEP DISORDER (sleeps seven hours, but now he is sleeping between nine and ten hours), BEDRIDDEN (In bed for two days), PAIN (Sore), FATIGUE (fatigue) and MYALGIA (Muscle soreness) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], LEVOTHYROXINE, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and LAMOTRIGINE for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced BEDRIDDEN (In bed for two days), PAIN (Sore), FATIGUE (fatigue) and MYALGIA (Muscle soreness). On an unknown date, the patient experienced SLEEP DISORDER (sleeps seven hours, but now he is sleeping between nine and ten hours). At the time of the report, SLEEP DISORDER (sleeps seven hours, but now he is sleeping between nine and ten hours), BEDRIDDEN (In bed for two days), PAIN (Sore), FATIGUE (fatigue) and MYALGIA (Muscle soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, Body temperature: unknown (High) Spike in temperature.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication include Iron supplement 28mg. No treatment drugs were reported.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.  Patient gave consent to safety for Follow-up.
Itching; This is a spontaneous report based on the information received by Pfizer (Reference ID: LRN3610234) from a contactable healthcare professional.  A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified at a single dose for immunization. Medical history included seasonal allergic rhinitis, asthma, cough, diabetes and hypertension. Concomitant medication included budesonide, formoterol fumarate (SYMBICORT), fluticasone furoate (ARNUITY ELLIPTA), tiotropium bromide (SPIRIVA), montelukast sodium (SINGULAIR), prednisone, omeprazole, montelukast, losartan, formoterol fumarate, mometasone furoate (DULERA) and azithromycin. On an unspecified date, it was reported that the patient experienced itching. The outcome of the event was unknown.  Information on the batch number has been requested.
12 hours after Moderna #2: low fever, body aches, headache started. Felt fine 10 hours later the next morning.
Clammy, short breathing, headache, sweating, shivering, shaking, loss of control on my limbs.
High temp 1.5 days after shot, severe chills, body aches headaches, Symptoms are getting better but I?m into day 3 and still have a temp with moderate headache
Symptoms started a week later. Severe pain in the right shoulder. In the morning cannot lift my right arm up to the side of my body. Lifting it forward showed no signs of pain. Then during the day and night, pain in both knees and ankles needing to hold the banister to walk up or down 1 step at a time.  Also developed swelling and in my lower legs. Bought special circulation knee high socks. Also pain in both feet. Went to the doctor and they prescribed medication I chose not to take. Opted for Tylenol 650 mg. I am not one to take medications, especially when they cannot determine the root causes. Dr. prescribed an ultrasound, right shoulder and also legs for circulation issues that I did not have before. I walk a lot in my job and do many physical tasks with no fatigue of pain before the vaccination. Am overweight but healthy and strong. I was a competitive bodybuilder in my late 20's and early 30's. I do my own gardening, mowing, mulching and planting etc and throughly enjoy it with no fatigue or pain at all before the vaccination. Now I can barely make it through an hour of activity without pain. Normally I have always had a high threshold for pain and heal fast. However this new set of conditions have me perplexed. I did some research on the vaccine and now I understand why I am all of a sudden having these issues. "Joint and Muscle Pain" The issue is, why is it lasting this long? It has been over a month since my second dose of the Vaccine. As a note ... I had a fall at work in March where I injured my right hand, no fractures were noted in x-rays. Just a bone/muscle bruise in the thenar region. I went through physical therapy and after 3 weeks it healed. My 1st vaccine dose was March 9, 2021 and I chose to have the vaccine administered in my left arm. 800 Mg of Ibuprofen was given but stopped taking it by the time I had my first vaccine. No other complaints until after my 2nd dose in April. At first I attributed the joint pains to the fall, however, the time line does not correspond, since these new pains started after April 6 (my first vaccine dose.
Continues to complain of pain in area where injection was given. Elliptical area present. right lateral thigh.
Experienced soreness in injection site  just like I experienced after first injection  which was received on June 7, 2019.  Unlike the first injection, this time I felt extreme fatigue at bedtime.  Around 2 AM I awoke with a headeache and nausea.  I vomited and continued to feel nauseous with a headache for the rest of the night.  The following  day I had chills and  felt fatigued all day.
1st given over 6 monts ago, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose ( 0.5 ml via intramuscular route) has been over 6 months).   On an unknown date, the patient  did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 08-SEP-2022 Reporter's Comments:  The patient stated she received 1st dose (did not provided date) but she did not get 2nd dose yet and it had been over 6 months. She did not want to disclose any personal information. Education and website provided. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of vaccine after 1st dose, which led to incomplete course of vaccination.
I woke up at 8am on Monday morning, with my heart pounding very fast and had chest pressure.  I also had a sweaty hands.  I went to the urgent care and they did a EKG.  The advised me to go to my PCP.  My PCP advised me to wear a halter monitor.  They noticed I was having a lot of PCV's which they now have me going to see a cardiologist for on July 21st.   When I started having the symptoms I was having it everyday, now I am having it every 3 to 4 days.  I am still having shortness of breath and a painless chest pressure.  My heart rate is also elevated like I am exercising when I am sitting still.
ADULT OBSTRUCTIVE SLEEP APNEA ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIA 2/26/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a six-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the first dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Information has been received from a medical assistant concerning a 19 year old female with no pertinent medical history and had an allergy with BIAXIN who on 08-SEP-2009 and 12-NOV-2009 was vaccinated intramuscularly with the first and second 0.5 mL dose of GARDASIL (dose 1 LOT# 0702X and dose 2 LOT# 0702X). There was no concomitant medication. Three hours after vaccination, the patient experienced body itching and body heat. At five hours after vaccination, the patient experienced chest pain and went to the emergency room. Subsequently, on an unspecified date the patient recovered from body itching, body heat and chest pain. The reporter considered the body itching, body heat and chest pain to be other important medical event due to the patient possibly received oxygen in the emergency room. Additional information has been requested.
Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. From an unspecified date in June 2015, the patients were administered an unspecified number of improperly stored doses of RECOMBIVAX HB (lot # was reported as J002621, expiration date 29-NOV-2015; strength, route and dose unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe chills followed by sweats during part of the night.  No treatment.  Felt totally fine the next morning.
presents with difficulty breathing associated with dizziness/presyncope.  Called EMS and received duoneb and solumedrol PTA with improvement.  Has had generalized body aches and dyspnea for three days.  Dyspnea worsened this morning.  Felt like was going to black out.  No fever.  Of note, received first COVID vaccine 4 days.  otherwise complains of calf cramping bilaterally, left greater than right.  Diarrhea twice yesterday.  No vomiting, no abdominal pain.  Complains of bloating and acid reflux.  All other systems negative
This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 06-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N013279, expiration date 28-APR-2019, for prophylaxis (Strength, dose, route and frequency were not reported). The M-M-R II was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The temperature excursion was of 9°C to 25°C, during 8 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA006448: US-009507513-1802USA007580: US-009507513-1802USA007576: US-009507513-1802USA007577: US-009507513-1802USA007578: US-009507513-1802USA007579: US-009507513-1802USA007573: US-009507513-1802USA007572: US-009507513-1802USA007575:
A few days after receiving vaccine in left arm he developed pain left shoulder and left side of neck.  This has persisted and worsened.  Doctor cannot find any explanation.   No apparent swollen lymph nodes.
mom states pt had t102.8; the day p/vax  lasted 1 day; no fever or any problems x 1 1/2 days p/that; had sz & pale & hands & lips were purple; went to ER;
Right after injection felt heaviness in left arm. After five minutes  felt a cool, heavy sensation in her left temple, which has persisted for several hours. Was put on 40mg of prednisone by allergist to prevent a reaction since 1/21/21 because of reaction to first dose of the vaccine.
April 7, woke up with a headache, took ibuprofen. A few hours later, started feeling hazy, lightheaded and had trouble concentrating while working from home. Felt like I was going to pass out. Took a break from computer screen, symptoms appeared to subside.  An hour later, same haziness feeling came back. Thought I was going to pass out again. Called 911. ER diagnosed  me with near syncope. Told me to keep an eye on symptoms and come back if things worsen. I informed them I had received one dose of vaccine, they didn?t seem to think it was related.  Symptoms have slightly improved since, but still have bouts of dizziness four days later.
22MAY98 pt recv vax & 28MAY98 3 vesicles appeared @ site;5JUN98 a 2x2cm area of raised irregular erythema appeared w/the original vesicles scabbed & groups of not quite fully formed vesicles;erythema;whole patch was pulsating;herpes zoster
Admitted for shortness of breath secondary to COVID-19 pneumonia. Tx w/ steroids, zinc, bronchodilators; did not require O2.
Patient had a lot of pain after the GARDASIL shot. She started to get headaches and dizzy spells causing her to miss a lot of school. On 10/29/14, I took Patient to see Dr. because she had been dizzy and nauseous for 3 days. He referred us to an ENT. The ENT did a tilt table test and determined her dizziness to be a cardiac issue. On 10/31/14, patient was diagnosed with POTS by Dr., a pediatric cardiologist. She did not have problems like this before. Patient was an elite soccer player.
lost of taste and smell; lost of taste and smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "lost of taste and smell". Additional information: Patient was asking about the Pfizer covid vaccine and he already got the 2nd dose in 5 doses and experienced lost of taste and smell. He asked if he should still continue taking. Patient asked if there have been previously reported before and if not would there be other problems that can correlate to his symptoms like pancreatic cancer.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a pharmacist referring to a 52 year old female patient. The patient had no drug reactions/allergies. On 20-JUN-2015 the patient was vaccinated with a dose of ZOSTAVAX, lot # K009770, expiry date 09-OCT-2015, subcutaneously (dose was not reported). Information regarding concomitant medication was unspecified. On 21-JUN-2015, the patient developed an "area of redness wrapping around the arm around the site of ZOSTAVAX injection". The patient went to see the pharmacist and seek medical attention. No lab diagnostics studies were performed. On an unspecified date, the patient started CLARITIN and BENADRYL for the redness. The patient had not recovered. Additional information has been requested.
pt recv vax 19FEB96 & exp inj site swelling & erythema extending from the elbow to the shoulder;
The patient felt fine after receiving the vaccine other than having a sore arm. This is being reported because the patient received a dose of Moderna 9 days earlier and should not have received this vaccine.
Rapid, irregular respirations; temp inc to 102.5; very irritable; sx occurred in the afternoon; DTP given in AM; Pediaprofen was given;
Dr from one clinic calls this clinic at 15:45 PM on Friday 16MAR12 re 37 y/o f who presents to the clinic he was calling from with growing area of erythema. pruritus at SC injection site LUE at 48 hours s/p receipt of live virus YF and varicella vaccines, given by her medic around noon on 14MAR12. The patient endorses history of chicken pox (disease) at 13-14 yrs of age, thus (?) need for varicella vaccination. Varicella immunization given on (14MAR12) is not documented in records as yet by medic, but YF vaccine given on same date is documented. The patient says she is sure that she was given both YF and varicella, SC in LUE. Medic reports patient to have 11 x 13 cm area of erythema and swelling on posterior aspect of left arm, extending from pt's left axilla to just above pt's left elbow. Per dr, there are also some small pruritic, fluid-filled vesicles/blisters over the initial area of redness, warmth and itching, which measured 4x6 cms in size yesterday (15MAR12) and is demarcated with a black pen. Today (16MAR12), the erythema, swelling, warmth and pruritus have increased to 11 x 13 cms, extending from pt's left axilla to just above her left elbow. Per dr, pt had a low grade fever and malaise yesterday and has the described blistering around the inject site today, with impressive increase in erythema and swelling. No induration, fluid wave or visible pus. NOTE: At f/u visit to clinic on 21MAR12, pt states that she found her old Yellow Immunization Card which indicated that she also received a dose of varicella in OCT of 2006 before going to work.
Broke out in hives 37 hrs after vaccinations. Hives systemic - worse on face. Parent gave dose BENADRYL - hives resolved for couple hours - then came back. Parent gave 2nd dose BENADRYL - hives resolved. Hives continue to return daily in the evenings - takes BENADRYL - they resolve.
Presented 6-04-08 to ER with Periorbital Cellulitis. RX Gentamycin opthalmic & Augmentin.Retrnd to Outpt clinic 6-06-08 with worsening R eyelid redness/discharge & multiple vesicles from mid upper eyelid to nasal bridge with lid edema. Single round red lesion R nare, few R upper lip, one on central tongue and 2 center of chin. DX Right Periorbital cellulitis with HSV or VZV (second suspected) with secondary bacterial cellulitis possible. Admitted for IV Acyclovir Viral culture done, pending.  06/23/2008 MR received for DOS 06/6-9/2008 with D/C Dx:  Periorbital Cellulitis.  Diarrhea 2' to abx.  Probable trigeminal distribution herpes zoster, culture pending. Pt seen in ER 2 days prior to admission with eyelid erythema and dx with periorbital cellulitis.  Started on abx.  Returned with worsening eyelid redness and multiple scattered vessicles from eyelids to nasal bridge and several oral and chin lesions. (+) eyelid edema (almost swollen shut) with ptosis and discharge. (+) fever, cough and fussiness. Suspected HSV or VZV with HSV (+) culture of eyelid d/c.  Tx with Acyclovir, Zosyn and Septra. Fever down and d/c 6/9/08.
pt recv vax NOV96 & exp diarrhea, weight loss & flu sx beginning 7DEC96;sx still persist;pt is taking glucose for diabetes & an unk pain med for migraines;pt indicated had been vaccinated w/one of the recalled lots but was unable to ID lot#
This spontaneous report as received from a 73 year old consumer with pencillin allergy and none pertinent medical history refers to herself. On 09-OCT-2013 the patient was vaccinated with ZOSTAVAX injection, subcutaneously, standard dose (lot number and expiration date not provided). Concomitant medications included aspirin 81 mg. On 13-OCT-2013 the patient had a stroke. The patient sought medical attention with her physician who sent her be hospitalized immediately. She stayed over night at hospital where she received various tests including: Computerized Axial Tomography(CAT), scan, Magnetic Resonance Imaging(MRI) and an ultrasound on her neck and heart. The patient also wore heart monitor. Treatment for adverse event was given - PLAVIX. The testing conducted during her hospital stay revealed that she had suffered a stroke. The outcome of stroke was reported as recovering/resolving. The relatedness between vaccination with ZOSTAVAX and stroke was not reported. Additional information has been requested.
Patient reports swelling of upper left eye lid approximately 1 hour after receiving Pfizer COVID-19 vaccine. Reports that nothing different was done that day other than receiving her vaccine. She has not taken any medication at the time of reporting this. Denies any vision changes or other symptoms besides the upper eye lid swelling.
RIGHT ARM WITH SIGNIFICANT SWELLING, ERYTHEMA,WARMTH.  NON-TENDER TO PALPATION. NO STREAKING, KEFLEX 250/5 7.5 ML BID FOR 10 DAYS.
Elevated Creatinine 1.43mg/dl 4 months after 2nd injection. Chronic kidney disease stage 2, 15 Dec 2022 Chronic kidney disease stage 3, 19 April 2022
devel hives on lt leg & lt arm; (no SOB or dyspnea, no edema) 2 days p/vax no other sx;did not seek medical attention; mom thinks it may be heat rash; still has rash on 2APR96;
Large elliptical rash, raised and itchy, developed 1 inch below injection site.
large bruise the size of a baseball at the injection site; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6203) via an unspecified route of administration, administered in Arm Left on 13Mar2021 13:40 at the age of 62-year-old as dose 1, single for covid-19 immunisation. The patient's medical history was none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021, patient experienced large green and yellow bruise; each day it got darker and it seemed to get a little larger. For 5 days she had a large bruise the size of a baseball at the injection site. It seems to be fading now. Adds when they draw blood from inside of her elbow she sometimes gets a small bruise but never like this and she never had a reaction, like a bruise like this with any other vaccine. Patient did not visit emergency room/physician office in response event. She is planning to receive the second dose of the vaccine on 03Apr2021. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "vitamin d deficient" (unspecified if ongoing). Concomitant medication(s) included: XYZAL. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Facility type vaccine was other. No other vaccine in four weeks. Other medications in two weeks was Xyzal and multivitamins. No Covid prior vaccination. No Covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Soreness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional case details were reported as follows: The reporter stated that the patient experienced soreness after her first dose in October 2019. The reporter consented to follow up. No further details were provided at the time of reporting.
Nausea, hives, vomiting, fever 101, fatigue lasting 2 days.
Sudden frequent urination and incontinence post 4 hours after 2nd dose. Continuing through  next day post injection. Currently unresolved.