chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchiness in the eyes; Arms were red; Arms were patchy; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (Itchiness in the eyes), ERYTHEMA (Arms were red) and RASH (Arms were patchy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced EYE PRURITUS (Itchiness in the eyes), ERYTHEMA (Arms were red) and RASH (Arms were patchy). At the time of the report, EYE PRURITUS (Itchiness in the eyes), ERYTHEMA (Arms were red) and RASH (Arms were patchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
LOSS OF VOICE; CHEST TIGHTNESS; CRAMPS IN THE STOMACH; SORE THROAT; BAD HEADACHE IN THE BACK OF THE NECK; NAUSEA; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced loss of voice. On 12-APR-2021, the subject experienced chest tightness. On 12-APR-2021, the subject experienced cramps in the stomach. On 12-APR-2021, the subject experienced sore throat. On 12-APR-2021, the subject experienced bad headache in the back of the neck. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad headache in the back of the neck, sore throat, nausea, loss of voice, cramps in the stomach, and chest tightness. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
This case was reported by a healthcare professional and described the occurrence of vaccination failure in a 53-year-old female subject who was vaccinated with ENGERIX B. On an unspecified date the subject received 3rd dose of ENGERIX B (unknown). The subject completed the hepatitis B vaccination series between 1992 and 1994. A serology titer was not completed after the series, so protection status was not known. The subject developed symptoms (not specified) of hepatitis B in September 2007 and was hospitalizes for an unknown period of time. The healthcare professional considered the events were clinically significant (or requiring intervention). In January 2008, the events were resolved. The healthcare professional considered the events were probably related to vaccination with ENGERIX B.
Cold sores around the mouth; swollen lymph under chin; Swollen and pain on chin; Swollen and pain on chin; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24May2021 at 20:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medication included amoxicillin (AMOXICILLIN). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28May2021, the patient experienced swollen and pain on chin, swollen lymph under chin and cold sores around the mouth. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events Cold sores around the mouth, pain on chin, swollen on chin and swollen lymph under chin were not resolved at the time of this report.  The lot number for the vaccine BNT162b2, was not provided and will be requested during follow up.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 16-JAN-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of the several reports from the same source. Additional information has been requested.
really bad; couldn't raise head up for like 2 days; achiness; tiredness; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (really bad), MUSCULOSKELETAL STIFFNESS (couldn't raise head up for like 2 days), MYALGIA (achiness) and FATIGUE (tiredness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027K20A) for COVID-19 vaccination.     The medical history was not provided by the reporter.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced FEELING ABNORMAL (really bad), MUSCULOSKELETAL STIFFNESS (couldn't raise head up for like 2 days), MYALGIA (achiness) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 22-Jan-2021, FEELING ABNORMAL (really bad), MUSCULOSKELETAL STIFFNESS (couldn't raise head up for like 2 days), MYALGIA (achiness) and FATIGUE (tiredness) had resolved.        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.   No concomitant medications were reported.   This case was linked to MOD-2021-395732, MOD-2021-395733 (Patient Link).
Sunday December 19, 2021 patient was exhausted & then began having a sore throat & cough, both kids also started feeling sick Sunday night.  By Tuesday the kids had a virtual sick clinic appt & were sent for flu & covid tests which came back negative. Patient went to get tested and his Covid test came back positive - by that point he had a slight fever as well.  Tuesday night he had a fever of 102 - did alternating Motrin & Tylenol, fever only reduced to 100.  Congestion increased, exhaustion continued & the fever/sweats/chills continued.  Wednesday night he thought the fever broke & was doing better only to have it come back Thursday.  Sunday December 26 he was not as exhausted and was his first day without a fever,  Today 12/27 he still has the cough & congestion.
Two weeks after my last shot I was in extreme pain all over my body and had to use a walker and cane to get around. No appetite, very weak and tired.
The patient present wound infections. The patient surgical wound opened up. There was a mild amount of drainage and complained about increased pain.
This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow up information has been received from a nurse concerning her 19 year old daughter who is a student with no medical history allergies, or illness at the time of vaccination, who in January 2007, was vaccinated with a first dose of GARDASIL. She was vaccinated in the left deltoid with a second dose in approximately March 2007 or early April 2007. Concomitant therapy included YASMIN. The patient experienced a stiff neck on the left side and neck pain after vaccination with the second dose of GARDASIL. The symptoms began at least 24 hours after the vaccination and resolved after 72 hours. The pain radiated from the shoulder of the arm (arm unspecified) up to her neck. The patient sought unspecified medical attention. Ibuprofen (MOTRIN) was taken for the symptoms. No laboratory diagnostic studies were performed. At the time of the report, the patient had recovered. No product quality complaint was involved. Additional information is not expected.
Not eating, not responding well doesn't try to get up- rash covering body.  MD dx as stomach virus
Patient received vaccine at clinic for work purposes on 19 April 2022. He returned in less than an hour complaining of "itchiness all over his body" and he felt like he had "trouble swallowing." Patient's vital signs were recorded. I administered 5 mL of oral Cetirizine and Hydrochloride with the permission. Vital signs were normal and patient did not feel any changes after medication administration. Patient sent to primary care provider's office to be monitored then sent home after receiving Zyrtec.
he could not get out of bed for 2 days after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (he could not get out of bed for 2 days after the 2nd dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (he could not get out of bed for 2 days after the 2nd dose). At the time of the report, BEDRIDDEN (he could not get out of bed for 2 days after the 2nd dose) had resolved.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-432545 (Patient Link).
Extreme inflammation, nausea, dizziness, fever reaching 101.9 lasting an entire day impacting ability to work, fatigue first day after shot. Mild pain and inflammation over whole body with low grade temp on day two.
shoulder upper back shoulder bldes, hands, knees-arthalgia & myalgias; Pred-Naprosyn-APAP#3;
Information has been received from a health worker referring to a patient of unknown age and gender. On 28-MAY-2015, the patient was vaccinated with the first dose of PNEUMOVAX23 (dose, strength, lot # and expiration date unknown). On 29-OCT-2015 the patient was vaccinated with the second dose of PNEUMOVAX23 (dose, strength unknown, lot # L017265, expiration date: 10-FEB-2017) (extra dose administered). No adverse effect was reported. Additional information has been requested.
This spontaneous report as received from a certified medical assistant, refers to an unknown number of patients of unknown demographics. The patients' concurrent conditions and medical history were not reported. On an unknown date in 2013, an unspecified number of patients received improperly stored Vaccine For Children (VFC) doses of RECOMBIVAX HB (dose and route, lot and expiration date were not reported) exposed to 20F and 30F on multiple occasions, from 22-SEP-2013 until 20-DEC-2013 (for 122 days. No adverse effects were reported (the reporter stated that the vaccines administered were RECOMBIVAX HB and VAQTA but on a second all was reported that no doses of VAQTA were involved in this excursion. Follow up information has been received from the certified medical assistant which reported that one of the patients was vaccinated with a dose of RECOMBIVAX HB (lot number reported as J0030722) on 26-SEP-2013. This is one of several reports from the same source. J0030722 is not valid lot number for hepatitis b vaccine (recombinant). Additional information has been requested.
Patient had a very bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Patient had a very bad reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Patient had a very bad reaction). At the time of the report, ADVERSE DRUG REACTION (Patient had a very bad reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Left upper arm with diffuse swelling, redness no individual lesions, pulses are 2 positive and equal with slight decreased ROM of shoulder due to swelling and pain.
Received booster dose of Pfizer COVID vaccine on 10/6/2021, which is approximately the same time my pregnancy stopped progressing and resulted in a miscarriage. I was 5 weeks 5 days pregnant at the time of vaccination, and on 10/29/21 at an ultrasound it was determined the fetus stopped developing around 6 weeks gestation. I miscarried the pregnancy on 11/3/21.
Pt informed recovery nurse that she was feeling dizzy and had tingling to her left arm distal to vaccine injection site.  Pt is a/o x4 with normal speech, equal facial symmetry, and equal grip strength.  Pt is not c/o any itching, SOB, or orofacial swelling.  Pt was placed in position of comfort with feet elevated, given a bottle of water, and monitored in post-vaccination area.  Pt was hypertensive and stated that she did not know her normal blood pressure.  Pt was monitored until 0935 when she stated that she was no longer dizzy.  Pt was advised to seek immediate medical care should her symptoms return or worsen; Pt verbalized understanding.  Pt left facility without further incident.
Body aches, sore joints (mostly knees), tightness in the chest, tired, periodic headaches
Information has been received from a pharmacist and a fried concerning a 73 yr old male who on 25Oct05 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). In Oct 2005, the pt developed redness and swelling of the injection site arm. It was further reported that the pt developed significant swelling, redness and pain from top of the shoulder down to his wrist. The pt sought unspecified medical attention. At the time of this report, the outcome of the events were unk. Additional information has been requested.
The patient received the vaccine and about a minute or two after administration stated she didn't feel good and was going to pass out. Her husband set beside her as I went to get water as the patient had not ate or drank anything yet. The patient proceeded to pass out and 911 was called. The Fire Dept arrived and performed vitals and transported the patient to the ER for further testing.
Patient developed worsening chronic upper back pain. Myositis was revealed on MRI dated 5/6/2021. Patient went on to develop a severe HA in August 2021. Was diagnosed wit thrombosis of the left transverse and sigmoid sinus in 12/2021 after multiple MRI's were performed erroneously without contrast despite ordering provider's instruction.
Information has been received from a published article. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB vaccine, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient # 22 of 32, a 58 year old male. On an unreported date 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second dose of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 58 year old male on an unspecified date was vaccinated with his third dose of RECOMBIVAX HB vaccine (lot number, route and site not reported). There was no concomitant medication. One day after vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of retinopathy. The authors stated the RECOMBIVAX HB vaccine may have possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB vaccine (WAES #1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02346, WAES # 1004USA02348 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
hives and itching like similar  allergic reactions,   self treated with  benadryl
My arm where the shot was given has hurt for some time.  When I lay on it at night it will wake me up aching.  It is not swelled, hot and no signs of why it is this way.
Myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 26-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. Company comment-This literature-non-study case concerns a male patient aged 26 years with no medical history reported, who experienced the expected serious (medically significant) AESI event of Myocarditis about seven days after first dose of mRNA-1273 vaccine in covid-19 vaccination series. No information on risk factors, medical history, concomitant medications, detailed clinical course, lab details, cardiac studies, treatment received was available in the report. Outcome of the event was unknown at the time of report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-686175 (E2B Linked Report).; Sender's Comments: This literature-non-study case concerns a male patient aged 26 years with no medical history reported, who experienced the expected serious (medically significant) AESI event of Myocarditis about seven days after first dose of mRNA-1273 vaccine in covid-19 vaccination series. No information on risk factors, medical history, concomitant medications, detailed clinical course, lab details, cardiac studies, treatment received was available in the report. Outcome of the event was unknown at the time of report. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-686175:(27 YO female)
Experienced soreness on the injection site (left arm); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program . The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Experienced soreness on the injection site (left arm)". Additional information: Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 08Mar21 and was scheduled to get the 2nd dose 4 weeks after. Caller was asking if the vaccine will still be in the process for approval. She mentioned that she knows it was given an Emergency Use authorization. She was also asking if it was okay that she was scheduled for 4 weeks after the first dose. She read from papers that it is supposed to be 3 weeks. She was scheduled to have her second dose on 05Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 07-APR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA007355:
Information has been received on 29-JUN-2017 from a vaccine coordinator regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 26-JUN-2017 the patient received an improperly stored dose of PEDVAXHIB lot # M032150, expiration 21-APR-2019, intramuscular for prophylaxis. No adverse effects reported. The vaccine was stored between the temperatures of 47 degrees Fahrenheit to 77 degrees Fahrenheit for the time period of 50 hours. There were no previous temperature excursions reported. The call was made because of a data logger. No further information available. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA004392.
Chills, fever, muscle pain especially on the legs and the left side of the kidney. Tremors and has visited several emergency rooms as symptoms get worse. Patient had a prostate biopsy done on 4/26/21 a day before getting vaccinated. Patient is currently admitted to a Medical Center for symptoms related to the prostate. Bloodwork have been done and as of today he is presenting thrombocytopenia and low hemoglobin levels.
Hypersensitivity to touch all over body and joint pain, headache fatigue the day after vaccine administered. No medical intervention warranted
This spontaneous report was received from a Registered Nurse regarding a 12 month old male patient. There was no information about concurrent condition and historical medication. On 28-SEP-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX lot # K003422, expiration date- 06-MAR-2016, 0.5 ml, subcutaneous. No adverse event was reported. The outcome of the event was unknown. No Product quality complaint (PQC) was involved. Additional information is not expected because patient does not want to get contacted.