chrisvoncsefalvay/vaers-outcomes huggingface dataset:
not feeling well; oxygen level is not good; diarrhea; can't take in any food; JOINT PAIN; very tired; muscle pain; chills; nausea; very high fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), OXYGEN SATURATION DECREASED (oxygen level is not good), DIARRHOEA (diarrhea), FOOD INTOLERANCE (can't take in any food) and ARTHRALGIA (JOINT PAIN) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, DULOXETINE HYDROCHLORIDE (CYMBALTA), ESOMEPRAZOLE, FAMOTIDINE and LEVOTHYROXINE for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced MALAISE (not feeling well), OXYGEN SATURATION DECREASED (oxygen level is not good), DIARRHOEA (diarrhea), FOOD INTOLERANCE (can't take in any food), ARTHRALGIA (JOINT PAIN), FATIGUE (very tired), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea) and PYREXIA (very high fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, MALAISE (not feeling well), OXYGEN SATURATION DECREASED (oxygen level is not good), DIARRHOEA (diarrhea), FOOD INTOLERANCE (can't take in any food), ARTHRALGIA (JOINT PAIN), FATIGUE (very tired), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea) and PYREXIA (very high fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Body temperature: 104 High, 103 High and 101 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Fever of 101F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 046B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced PYREXIA (Fever of 101F). At the time of the report, PYREXIA (Fever of 101F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2021, Body temperature: 101f (High) 101F.         No Concomitant Products were reported. Patient condition include Special needs Nonverbal. No Treatment information was reported.   This case was linked to MOD-2022-560526 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: Follow-up contains no new information
Developed Hashimoto's disease/autoimmune thyroiditis within 6 months of vaccination.
Patient  was very nervous about the vaccine and stated she had previous history of seizure after the initial dose of Janssen. She was hyperventilating and sweating during the vaccination. She was okay after the vaccine but feinted very briefly with body stiffness shortly after the vaccination. Patient regained consciousness immediately
Pt states approximately 2 hours post vax. Arm became very swollen from shoulder to fingers. Red, warm to touch. Client states had a fever (never took temp) and began vomiting. Called to Health District instructed to take Tylenol and Benadryl if worsen to report to PCP or hospital. Pt states symptoms lasted approx 4 days.
after 2nd DOSE patient said they developed pain at the injection site, a slight rash and redness appeared as well. was feverish and had chills as well. took tylenol to help with the fever and pain.
Day 9, 10,  11: Red bite? Rash below injection site, right arm. Itchy.
Reaction on arm began about 8 days later when first dose was administered. Red and itchy rash appeared around the injection site. This was present on my arm for the whole day. The next day rash reduced down to a ring look around the arm about 4 inches wide in a circle. Today is day 3 from when the the rash appeared and my arm is still a bit swollen and itchy with the ring circle around it.
Swollen left axilla and portion left breast. Heaviness in arm and tingling fingers. Lasted for 5 days. Treatment : Warm soaks applied to axilla.
This spontaneous report as received from a registered nurse (nurse manager) refers to an employee, a female patient of unknown age. Information regarding medical history was not provided. On 26-SEP-2012 the patient was vaccinated at the office with a single dose of ZOSTAVAX subcutaneously in the right arm. No other co-suspects were reported. No concomitant medications were reported. On 27-SEP-2012, the patient came back to work and experienced a 4 inch round, red, hard, hot area at the injection site. The patient did not receive treatment for the event. The patient did not seek any medical attention. The outcome of '4 inch round, red, hard, hot area at the injection site' was reported as not recovered. A reporter causality was not provided for '4 inch round, red, hard, hot area at the injection site' and ZOSTAVAX. Additional information is not expected.
The patient reported that he had an active case of shingles that was treated with VALTREX 1 gram TID x 7 days. He reported that the treatment was effective in clearing up the rash. 20 days after starting treatment with VALTREX the patient received the ZOSTAVAX shot. He reported that the next day his Legs, back and arms started break out again. This was the same area that he reported the original rash had presented.
Red raised area on R D approx 50 mm in size c/o pain @ site and warm to touch Temp 97.5 TWIN #1
PMH:  asthma, MS; states fell 2 wks ago @ home and has had pain in chest area since; tested positive for COVID; COVID pneumonia; hypoxic; on 6 L O2 via NC saturating @ 92%; treated with decadron, antibiotics, remdesivir; placed on BIPAP; DNR; condition continued to decline; comfort measures; BIPAP was dc'd and pt died in the hospital
Tachycardia, hypertension, flushed, felt vaccine rushed through the body.
Immediately had lowered  blood pressure and was dizzy.  In three hours had chest pain and shortness of breath.  General pain in chest which has worsened over the last 3 1/2 weeks
developed cancer; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer was unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided but it could be 66 or 67 years. The patient received the first dose of Shingrix and developed cancer so did not get the second dose. The follow up consent was granted. This case was a medication error without harm.
10-6-16 Woke up with lethargy. Progressive muscle/joint aches and uncontrolled chills. Did not check temp. Rash appeared - small pin head size red flat dots all over body except none on face. No itching, chills/aches resolved in 24 hours. Rash resolved - 7 days.
Bones and joints pain, chills and fever, bad headache, eyes pain. Cough.; Bones and joints pain, chills and fever, bad headache, eyes pain. Cough.; Bones and joints pain, chills and fever, bad headache, eyes pain. Cough.; Bones and joints pain, chills and fever, bad headache, eyes pain. Cough.; Bones and joints pain, chills and fever, bad headache, eyes pain. Cough.; Bones and joints pain, chills and fever, bad headache, eyes pain. Cough.; Bones and joints pain, chills and fever, bad headache, eyes pain. Cough.; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient (not pregnant) received first dose of BNT162B2 (Lot number: Pcj1685), intramuscularly in left arm on 23Dec2020 18:30 at single dose for COVID-19 immunization. Medical history included anxiety, depression, seasonal allergy all from an unknown date and unknown if ongoing. Concomitant medication included celecoxib (CELEXA), biotin, curcuma longa (TURMERIC), calcium, doxylamine. The patient previously took Levofloxacin (LEVAQUIN) and experienced allergies. The patient experienced bones and joints pain, chills and fever, bad headache, eyes pain, cough all on 24Dec2020 05:00. Treatment (Around the clock Motrin) was received for events. All events were reported as non-serious. Facility type vaccine was administered in hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events was not resolved.
Information has been received from a physician concerning a 7 month old male patient with perforated anus and G-tube who on approximately 05-SEP-2011 was vaccinated with ROTATEQ (lot # not reported). On approximately 08-SEP-2011 (reported as "approximately three days following the vaccination") the patient began experiencing nausea, retching and burping up more gas than usual. At the time of reporting, the patient had not recovered. The patient sought medical attention via office visit. Additional information has been requested.
BlurredVision, Dizziness, Headache, Fever, BODY ACHES, CHILLS, NAUSEA, SWOLLEN COLLARBONE, NECK AND EYE, RUNNY NOSE, NAUSEA Narrative:
ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXIA
Reports fluttering in chest, chest pressure, lightheaded, dizziness, increased blood pressure increasing throughout day. On 8/21/2021, the day after receiving vaccine, reported symptoms continued through the weekend, client reports the symptoms felt intense at times, reports symptoms did get better on 8/24/21, client did go to her doctor, and doctor offered an ekg and holter monitor which client refused at this time.
Patient had redness and swelling at site. Patient complained of itching as well. Reports no allergies.
2" diameter on outer surface (L) arm-reddened and hot. Little bit of redness on inside of (L) arm across from where shot was given-a little warm but not edematous, just a little bit erythematous. No swollen lymph nodes in (L) axilla but did complain of some vague tenderness.
Immunization was administered at 2:41pm, aprox 2:45pm patient slumped over in clinic room chair- with snoring respirations, bilateral pupils dilated 5mm, became rigid, diaphoretic, and started having tonic clonic seizure activity lasting for approximately 4 mins, patient was lowered to ground for safety- 911 was activated- patient slowly regained consciousness post event- patients blood glucose = 100. HR 110 SPO@ 98%RA; patient denies previous seizure activity or history of seizures, denies drug abuse.  Patient is transported to local hospital.
Localized swelling, redness, pain and rash LAT seen by physician treated with Benadryl.
Information has been received from a health professional concerning an adult female in the health care field who was vaccinated with a first and second dose of varicella virus vaccine live. It was reported that on antibody titer was drawn 2-3 weeks after the second dose and the result came back equivocal. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Pt received her first dose of the COVID19 Moderna vaccine. While sitting in observation pt reported feeling like her heart was beating fast and loud. BP 118/80, HR 80, O2sat 98%, evaluated by  MD. Pt refused EMS evaluation and reported feeling better within a few minutes.
Malaise for 3 days, eye conjunctivitis. Feeling no malaise now, but advised pt to get eyes checked out for infection.
Breakthrough case admission after 3 vaccines Pfizer 2/5/21 Lot# EL9216;  Pfizer 2/26/21 Lot# EN5318;  Pfizer 12/17/21 Lot# FL3197
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No medical history was reported. On an unknown date, the patient was vaccinated with an expired dose of ROTATEQ, (lot#, expiry, dose, route not reported). No concomitant medications were reported. No adverse effect reported. The pharmacist did not have the date of administration or the lot number and expiration date of the ROTATEQ. Additional information has been requested.
Itchy eye; Swollen; Red; Itchy; Shot site is itchy and red and hot; Shot site is itchy and red and hot; Shot site is itchy and red and hot; Red sore by her right eye/ It was super red; Red sore by her right eye; Her arm was sore a little bit; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 11Mar2021 15:10 (at the age of 65-year-old) (Lot Number: EN6206) as dose 1, single for COVID-19 immunization. Medical history included none. There were no concomitant medications. Historical vaccine included shingles vaccine 4 years ago and experienced a scar (a red mark and a scar, about 6 inches below where the needle should have gone). The patient did not receive any other vaccination prior to COVID vaccine. The patient experienced her arm was sore a little bit, nothing more than any other shot and then by Monday, 15Mar2021, nothing hurt, it was nothing. On 18Mar2021, patient got a red sore by her right eye and she thought she might have scratched her eye. On 19Mar2021, the shot site was itchy and red and hot. It was not painful but it was itchy and hot and reported it was totally gone a couple of days ago. Patient reported she did try a new undereye care cream for wrinkles that she started maybe Monday, 08Mar2021, of last week. She was thinking maybe that was associated with her eye. She thought it might be a sty. She has been using warm compresses on her eye and reported that it was improving. On an unknown date, patient reported swollen, red, itchy and eye was itchy. The outcome of swollen, red, itchy and eye was itchy was unknown. The outcome of event eye pain was improving and outcome of shot site itchy and red and hot was recovered and outcome of all other events was unknown.  No follow-up attempts are possible. No further information is expected.
chills; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if prior to vaccination, the patient was diagnosed with covid-19. Since the vaccination, it was unknown if the patient had been tested for covid-19. On 01Mar2021 in late evening, patient experienced chills. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Painful lymph nodes; Fatigue; Tired low back; Severe headache; Sore arm; Sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 14:45 (Lot number: ER8730) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sulfa" (unspecified if ongoing), notes: sulfa causes nausea. Concomitant medication(s) included: LISINOPRIL; AMLODIPINE; VALACYCLOVIR HCL. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 26Mar2021 07:00, outcome "not recovered", described as "Painful lymph nodes"; FATIGUE (non-serious) with onset 26Mar2021 07:00, outcome "not recovered", described as "Fatigue"; BACK PAIN (non-serious) with onset 26Mar2021 07:00, outcome "not recovered", described as "Tired low back"; HEADACHE (non-serious) with onset 26Mar2021 07:00, outcome "not recovered", described as "Severe headache"; PAIN IN EXTREMITY (non-serious) with onset 26Mar2021 07:00, outcome "not recovered", described as "Sore arm"; OROPHARYNGEAL PAIN (non-serious) with onset 26Mar2021 07:00, outcome "not recovered", described as "Sore throat". Therapeutic measures were not taken as a result of lymphadenopathy, fatigue, back pain, headache, pain in extremity, oropharyngeal pain.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from an office manager refers to a 11 year old patient. No information about the patient's pertinent medical history, concomitant medications or drug reactions or allergies was reported. On 18-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # M044717, expiry date: 19-JUL-2019) (dosing details were not reported) for prophylaxis. The administered dose of GARDASIL 9 underwent a temperature excursion at 35 degree Fahrenheit for 5 full days. No adverse effects reported. No previous temperature excursions reported.  This is one of several reports reports received from the same reporter. Additional information is not expected as no further information is available.; Sender's Comments: US-009507513-1708USA002323: US-009507513-1709USA012712: US-009507513-1709USA012713: US-009507513-1708USA005405:
Information had been received on 06-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 27-JAN-2016 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 16-APR-2016, the patient was treated by a physician of an urgent care facility for the onset of a vesicular rash accompanied by symptoms of weakened immunity, which was diagnosed as severe Herpes Zoster, or shingles. The female patient has been prescribed gabapentin, VALTREX, LYRICA, VESICARE, "NERONTIN", and oxycodone-acetaminophen to help manage her painful symptoms.  As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Case number PHEH2015US000979, is an initial spontaneous report received from a medical assistant on 12 Jan 2015, and with a follow up report received from medical assistant on 02 Feb 2015. This report refers to a 12 year old male patient. Historical condition and concomitant medication were not reported. He was vaccinated with two doses of meningococcal ACWY vaccine (manufacturer and batch number: not reported) 0.5 ml intramuscular on 05 Dec 2008 (at 11 year of age) and on 15 Aug 2010 (at 12 year of age). These were given at another providers office, details are not available. Unsure whether the vaccine was MENACTRA (other manufacturer, batch number: not reported) or MENVEO (batch number: unknown). No adverse event was reported following this administration error. No further information was provided. Follow up report received from medical assistant on 02 Feb 2015. Updated vaccination details.
worsened swollen groin lymph nodes; swollen groin lymph nodes; swollen neck lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen neck lymph nodes), LYMPHADENOPATHY (swollen groin lymph nodes) and LYMPHADENOPATHY (worsened swollen groin lymph nodes) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No medical history provided by the reporter.     On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 01-May-2021, the patient experienced LYMPHADENOPATHY (swollen neck lymph nodes). On 04-May-2021, the patient experienced LYMPHADENOPATHY (swollen groin lymph nodes). On 06-May-2021, the patient experienced LYMPHADENOPATHY (worsened swollen groin lymph nodes). At the time of the report, LYMPHADENOPATHY (swollen neck lymph nodes), LYMPHADENOPATHY (swollen groin lymph nodes) and LYMPHADENOPATHY (worsened swollen groin lymph nodes) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment include Ibuprofen. No other medication reported. the patient race identified.
Patient developed a rash with itching all over his body and fever for 2 days after immunizations. No treatment. Patient reported symptoms to primary doctor one month after event.
Client stated that she began itching all over her body the next day. The itching continued until 10/27/10 when she spoke to a pharmacist and was told to take Benadryl for the itching. She took the Benadryl for 2 days and on the 29th the itching had stopped.  She denies any rash, hives, fever or difficulty breathing.
Fever chills soreness of injection site. Injection site is very tender. Fever over 100
This spontaneous case reported by a consumer, describes the occurrence of vaccination site rash (rash on injection site, her rash became worse) and vaccination site pruritus (itching) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 013M20A) for COVID-19 immunization. Concurrent medical conditions included drug hypersensitivity and allergy to antibiotic. On Feb 23, 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 25, 2021, patient experienced vaccination site rash (rash on injection site, her rash became worse). On Mar 15, 2021, patient experienced vaccination site pruritus (itching). At the time of the report, vaccination site rash (rash on injection site, her rash became worse) and vaccination site pruritus (itching) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
I had received 1st covid shot on 9/14/21 , had little pain in upper right arm at injection site in the evening.  Woke up on 9/15/21 pain radiated down right arm and right hand and fingers numb as if hand is asleep.  It is now 10/8/2021 and I am still having pain in upper right shoulder , in right elbow, down arm and my  hand and fingers are still numb and cold to touch.
12/21/21 presents to ED for "fall at home" "left-sided weakness" "shortness of breath and cough".  PMHx of "Arthritis, rheumatoid, COPD, COVID-19, Essential hypertension, benign, Lung cancer"