chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very Fatigue; Muscle aches; expected local reactions; This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 6th December 2019, the patient received the 1st dose of Shingles vaccine. In December 2019, less than a week after receiving Shingles vaccine, the patient experienced fatigue, muscle pain and local reaction. On an unknown date, the outcome of the fatigue, muscle pain and local reaction were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, muscle pain and local reaction to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication The health care professional stated that, on friday evening before the day of reporting, the patient received dos of Shingles vaccine and was still very fatigued with muscle aches with the expected local reactions. No further information provided.It was not confirmed that shingles vaccine was Shingrix.
This spontaneous report was received from a registered nurse, referring to a 4 month old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 31-OCT-2018 the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # R007986, expiration date 13-OCT-2019, for prophylaxis (strength, dose, and frequency were not reported). The temperature excursion was of 9 Centigrade degrees (°C) (9°C to 25°C), during 20 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
nausea, vomiting, lightheaded, syncope, chills, restlessness, joint pain, change in sleep patterns
developed pruritic erythematous plaque at injection site on L upper arm on day 8 after receiving vaccine
Patient received Pfizer dose#2 on 1/2/2021. Then approximately 3 weeks post vaccine, she began to experience acute upper arm/ clavicular joint pain  and bilateral hands were "cupped".   Received steroid treatment from PMD.
c/o dizziness;very tense; anxious; crying;chest tight p/lying down; BP 130/80;resp inc d/t hyperventilating; O2;benadryl;per protocol; pt had not eaten;ER;sl pale color; chest tightness;hosp for observation & tests;
This case was reported by a healthcare professional (the subject) and described the occurrence of fever in a 55-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Between June and September 2008, the subject received 1st dose of ENGERIX B (unknown). On an unspecified day between June and September in 2008, within four to eighteen hours of vaccination with ENGERIX B, the subject experienced fever, (horrible) headache, general malaise, and joint pain. On an unspecified date, the subject experienced flu-like symptoms. The subject was treated with TYLENOL or ADVIL for her flu-like symptoms. On an unspecified date between June and September in 2008, 48 hours after the start of the symptoms, the subject's fever, (horrible) headache, general malaise, and joint pain were resolved. The outcome of flu-like symptoms was unknown.
Congested, bronchospastic cough, dyspnea, shortness of breath, chest pain, palpitations, bilateral forefeet purple - warm, brisk refill, strong pulses.
4-12-21 10AM TC: PT STATES HER 'TINNITUS HAS BEEN WORSE THAN USUAL (HAS HX OF SAME) SINCE GETTING COVID SHOT'. SHE DID CALL HER PCP AND DISCUSS IT.
Itchy rash around the injection site.  About 2 inches in diameter. Not serious but wanted to report it. Started about a week after receiving vaccine and still having some itching and rash.  Using cortisone cream to treat itching helps some.
Pain  Narrative:  Side Effects: #1: day one - pain and discomfort (localized) #2: day one - pain and discomfort (localized) AND day two: fever, muscle ache, chills
headache; Pneumonia; covid-19; difficulty breathing from copd; Achey; tired; high fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) and COVID-19 (covid-19) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (difficulty breathing from copd), MYALGIA (Achey), FATIGUE (tired) and PYREXIA (high fever). On 12-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant) and COVID-19 (covid-19) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, PNEUMONIA (Pneumonia), COVID-19 (covid-19), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (difficulty breathing from copd), MYALGIA (Achey), FATIGUE (tired), HEADACHE (headache) and PYREXIA (high fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test positive: positive (Positive) positive. On 12-Apr-2021, Computerised tomogram: positive (Positive) positive for pneumonia.. On 12-Apr-2021, SARS-CoV-2 antibody test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient finished treatment with antibiotics and was tested positive for antibodies. Patient took Levofloxacin, inhaler (albuterol) and steroid dexamethasone medications as a treatment. There are no concomitant medication reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Based on reporter's causality history a positive SARS-CoV-2 viral test event is assessed as unlikely related to mRNA-1273   This case was linked to MOD-2021-095577 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Based on reporter's causality history a positive SARS-CoV-2 viral test event is assessed as unlikely related to mRNA-1273 MOD-2021-095577:
Pt waited 15 minutes, went to leave and made use of the public bathroom. When sitting, patient felt faint, weak, and dizzy. Pt reported this to leadership. VS were WNL. Pt was advised to wait another 15 minutes. Pt symptoms persisted for another hour and pt reported feeling unsafe to leave throughout this time. EMS was called at 1720 to assess pt. EMS arrived at 1725. After discussion with pt, pt decided to leave with EMS at 1748
This spontaneous report as received from a pharmacist via a company representative refers to a 53 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX, 0.65 ml (one dose), subcutaneous. On an unknown date, the patient experienced bruising and rash at the injection site after receiving ZOSTAVAX. The patient visited a physician however she did not received any treatment for the events. The outcome of bruising and rash at the injection site was reported as recovered. The causal assessment was not provided by the reporter. Product quality complaint was not involved. Additional information is not expected as consent to contact was not provided by the reporter.
Patient received vaccine after the expiry time allowed in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
pt recv vax OCt95 & devel multiple persistent, small papular lesions on lt side of abd;the lesions became vesicular & looked almost like herpes zoster;there was no itching or burning;
Patient experienced a headache starting 02/11/18 and continuing intermittently to the present 02/20/18. Acetaminophen has helped to relieve the pain.
(L) deltoid pain beginning on 03/04/2016 the day after getting a TDAP.
Chest pain, increased heart beat, chest tightness, light headed, arm pain, shortness of breath, can feel heart beating in chest
Pt experienced raised (bruised), red, hot to touch skin around injection site some but mostly a few inches below injection site that "cuffed" went all the way around arm. She states it burned and was itchy. She has found some relief with BENADRYL, Ibuprofen and cold compress. Full recovery is expected. Asked pt to keep us updated on her recovery.
A few after the vaccine dose 2 you couldn't see well prescription glasses, both eye were blurry, that latest for 2 weeks.  Swelling under the left arm that latest for 2/3 days
10 by 20 centimeter erythematous rash over left thigh at site of injection.
pt recvd vax & was supposed to recvd 1993 fluogen vax but instead recvd 1992 fluogen vax; this case is 1 of 3 pts who recvd inadvertent administration of the 1992 vax;
Patient still feels her ears hot and itchiness; COVID arm; immediate flushing of the face following vaccination; Hives on her foot; temperature on her ears; Rash on hands; A spontaneous report was received from a consumer concerning a 47-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced immediate flushing of the face following vaccination/ flushing, hives on her foot/ urticaria, temperature on her ears/ feeling hot, rash on her hands/ rash with seriousness criteria as medically important, covid arm/ pain in extremity, feels her ears hot and itchiness/ ear pruritus.  The patient's medical history was not provided by the reporter. No relevant concomitant medications were reported.   On 26 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 022m20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Feb 2021, the patient experienced immediate flushing of the face following vaccination and seven hours later hives on her foot, temperature on her ears and rash on her hands with seriousness criteria as medically important.  On 05 Mar 2021, after seven days of mRNA-1273 the patient experienced covid arm.  On 11 Mar 2021, the patient experienced feels her ears hot and itchiness.  Lab details were not provided by the reporter. Patient reported that PEG allergy test was scheduled on an unspecified date.   Treatment for the events included Benadryl tablets and allegra.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, immediate flushing of the face following vaccination, hives on her foot, temperature on her ears, rash on her hands were recovered on 26 Feb 2021.  The outcome of the events, covid arm, feels her ears hot and itchiness were unknown.; Reporter's Comments: This is a report 47-year-old female who experienced medically significant and unexpected serious events of rash, urticaria, flushing, feeling hot, along with nonserious unexpected pain in extremity and ear pruritus.  Event onset the same day as first dose mRNA-1273, with "COVID arm" at Day 7. Treated with Benadryl and Allegra. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
sore body, body feeling heavy, chills and sweats, not being able to sleep ( the night of getting the vaccine)  headache ( next day)
1/5 2200: Injection site soreness, fatigue 1/6 0600: Fever 99.9, chills, body aches, fatigue, nausea Treated with tylenol and zofran 1/7 1400: resolution of symptoms
reactions from 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (reactions from 2nd shot) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (reactions from 2nd shot). At the time of the report, ADVERSE REACTION (reactions from 2nd shot) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.    This case was linked to MOD-2021-036492 (E2B Linked Report).; Sender's Comments:  MOD-2021-036492:Cross-linked
The initial case was made invalid due to unspecified AE. Upon receipt of follow-up information on 28MAR2016 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician and nurse via a Pfizer sales representative. This physician reported for 3 patients. This is the second of three reports. A 17-year-old male patient of an unspecified ethnicity received TRUMENBA (batch/lot L13514. exp. date 21JUL2016) intramuscular on left deltoid at 0.5 ml single on 08MNOV2015. The patient medical history was not reported. The patient's concomitant medications were none. The patient experienced on 09NOV2015 large local inflammatory reaction and on 10NOV2015 severe headache, neck stillness and photophobia. The outcome for all events was reported as recovered on 13NOV2015. The patient was not hospitalized for the event.
Severe tinnitus in right ear with severe hearing loss.  I qualify for a cochlear implant. I was diagnoses by the ENT department, Dr. Oral steroids, Steroid injection into the inner ear.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Enlarged painful lymphadenopathy of axilla and groin  Narrative:
After administration of HEP A and Chickpox Vaccine.  Son stood, said he was dizzy, headache, and wanted to vomit.  Nurses and doctor helped to back to exam.  Patient passed out.  Dr. said his heart rate fell.  Patient was cold, pale, with headache, nauseous.  He was on exam table laying down with feet elevated.  Approximately 20 - 30 minutes of rest he was able to leave. We came home he had lunch but still has headache and somewhat pale the rest of the day and evening.
drug interaction with this vaccine; feeling extremely dizzy; head feels like it's on fire; This is a spontaneous report from a contactable consumer (patient's friend). A male patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; Batch/Lot Number and Expiry date were unknown), via an unspecified route of administration on 08Mar2021, Monday, at a single dose for covid-19 immunization; atorvastatin calcium (Batch/Lot Number and Expiry date were unknown), via an unspecified route of administration from an unspecified date to an unspecified date, at 20 mg for blood cholesterol abnormal (cholesterol problem); phenoxymethylpenicillin potassium (PENICILLIN VK; Batch/Lot Number and Expiry date were unknown), via an unspecified route of administration from an unspecified date to an unspecified date, at 500 mg for dental problem (tooth disorder); chlorthalidone (Batch/Lot Number and Expiry date were unknown), via an unspecified route of administration from an unspecified date to an unspecified date, at 25 mg for blood pressure abnormal (blood pressure problem). Medical history included dental problem (tooth disorder), blood pressure abnormal, blood cholesterol abnormal (blood pressure problem and cholesterol problem); all from an unknown date. The patient's concomitant medications were not reported. It was reported that patient seemed to have a quite severe reaction after he got the vaccine. On 10Mar2021, two days after vaccination, the patient experienced drug interaction with the vaccine. The reporter was sure about drug interaction with this vaccine as the patient also took blood pressure and cholesterol medicine along with Penicillin. Patient now felt extremely dizzy and felt like his head is on fire, all on 10Mar2021. The events were reported as non-serious. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Case number PHEH2013US021212 is an initial spontaneous report received from a consume on 09 Oct 2013. This report refers to an 18-year-old female patient. Her medical history included latex allergy. She was vaccinated with MENVEO (batch number: unknown) intramuscularly on 08 Oct 2013 at the college in medical facility. On the same day, she had vomited and was nauseated. Her mother stated that her daughter vomited approximately 10 hours after receiving MENVEO. She was still nauseated as of 09 Oct 2013. Final outcome of the events was unknown. No other information was provided.
Injection site red, itchy, warm to touch. Has pain in arm. Informed to take BENADRYL, TYLENOL and cortisone cream to area.
Breast cancer; This case was reported by a consumer via interactive digital media and described the occurrence of breast cancer in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. In March 2020, between 1 and 3 months after receiving Shingrix, the patient experienced breast cancer (serious criteria GSK medically significant). Shingrix was discontinued. On an unknown date, the outcome of the breast cancer was unknown.   It was unknown if the reporter considered the breast cancer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient received 1st dose of shingrix in February 2020 and in March 2020 patient was dignosed with breast cancer. The patient stated that not received the 2nd dose due to chemotherapy.
Breakthrough case of varicella-spots, but no fever. Confirmed by doctor. No treatment.
The patient is a 94 y.o. male with history of PAF, CHB, HLD presented to the hospital with generalized weakness   Acute Hypoxic Respiratory Failure COVID-19 Infection  Aspiration Pneumonitis Presented to the hospital with sore throat and generalized weakness for 3 days Was on RA on admission, CXR was non-acute, afebrile Episodes of vomiting early morning 12/9, and then subsequently on oxygen at 4L and then up to ventimask. Down to 5L 12/10 Repeat CXR with diminished lung volumes, interval progression of bibasilar atelectatic/consolidative changes since prior study.  CRP elevated and trending up on repeat Given hypoxia started on dexamethasone and remdesivir 12/9 Had worsening O2 needs so was started on antibiotics for possible aspiration Quickly improved in < 24 hours and now off oxygen. Stop remdesivir Procalcitonin normal, will stop antibiotics Continue decadron x10 total days   Generalized weakness + his leg gave up and unable to use his walker, keep sliding, did not fall  Wife at bedside, unable to take care of him at this level and requested SNF PT/OT consulted SW consult Discharge to SNF   Urinary Retention Patient incontinent at baseline Having some difficulty urinating 12/10 Underwent straight cath x 1 Now urinating better Continue to monitor   PAF CHB s/p pacemaker On warfarin Pharmacy consulted to dose warfarin   Goals of care with advanced directives Patient elected to be DNRCCA-DNI
a cold/cold-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (a cold/cold-like symptoms) in a female patient of an unknown age 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 NASOPHARYNGITIS (a cold/cold-like symptoms). At the time of the report, NASOPHARYNGITIS (a cold/cold-like symptoms) had not resolved.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Patient stated she had itching of her face and neck.  She has many allergies.  She took Benadryl immediately post vaccination.  She stayed in the recovery area for one hour.  She continued to have some itching but did not worsen or develop any hives etc.  MD from ED in to assess.  Patient discharged after 1.5 hours in recovery with no rash, swelling, edema, difficulty swallowing.  She is instructed to return to ED if any increase in symptoms.  Patient understood instructions.
Pt recvd DTP/OPV/HIB TITER & was given APAP then about 4 hrs later exp a high-pitched cry lasting 4 minutes; became pale & limp from head to toe, eyes closed & twitching of lt leg; Taken to ER; t99.7; sent home-asymptomatic;
It was reported that a 25 year old female pt received an Imovax Rabies vaccination on 3/15/01. Approx. 1 hour, after the injection, the pt developed a swollen face and "hot" in her neck. Seen by a physician the next day. No treatment given; is resolving. From additional correspondence received on 4/11/01, it was reported that the pt recovered from this experience. Additional pt, vaccine administrator and responsible physician information were also provided. This case is closed.
had Hepatitis D 3 days after First Pfizer Vaccine; This is a spontaneous report from a Pfizer sponsored program COVAX  support. This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) 1st dose via an unspecified route of administration on 12Mar2021 as SINGLE DOSE for COVID-19 immunization and hydrocortisone, neomycin sulfate, polymyxin b sulfate (CORTISPORIN). The patient medical history and concomitant medications were not reported. On Mar2021 the patient had hepatitis D 3 days after first Pfizer vaccine. It was reported that, second covid dose was given 03Apr2021. Caller was never asked about other injections at the time of the vaccine and was not supposed to get them so close together. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient arrived for vaccine visit. No concerns were voiced. Patient sat on bed and was administered 5 vaccines: Hep B, IPV, MENACTRA, Td and HPV. HPV was administered last. After the HPV vaccine was administered, the patient fainted. Patient was laid down on the bed and was unresponsive for 15-20 seconds. The nurse assessed the patient and vital signs were: BP 108/76, O299%, P67. Pt was oriented x3. No fall or injury was noted. patient felt better and ready for discharge. 30 minutes after HPV administration Patient reported to CMA that he was nervous and hadn't eaten.