chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Aches; low grade fever; chills; This spontaneous case was reported by a health care professional and describes the occurrence of MYALGIA (Aches), PYREXIA (low grade fever) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Undiclosed) for COVID-19 vaccination.     No Medical History information was 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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced MYALGIA (Aches), PYREXIA (low grade fever) and CHILLS (chills). At the time of the report, MYALGIA (Aches), PYREXIA (low grade fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information was not provided.   This case was linked to MOD21-091918, US-MODERNATX, INC.-MOD-2021-156255 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Significant follow-up - Cross linked numbers were updated by HCP; Sender's Comments:  MOD21-091918: US-MODERNATX, INC.-MOD-2021-156255:
Facility manager informed us that patient had a seizure on 3/17/21, which was 2 days after the vaccine was given (3/15/21) which then lead to a stroke.  Patient passed died on 3/17/21.
Approximately two weeks after receiving the vaccine (4/19/21), I was taken to the hospital in an ambulance. I had become become very faint and was experiencing intense pain in my left calve. I was diagnosed with DVT in my left leg.
In January 2022 I began to feel my heart fluttering with palpitations. I would also feel a stab-like pain. I did not have chest pain, just palpitations and then a real painful palpitation like a stab in my heart. This would happen when I was washing dishes and then it happened after I laid down. I went to the ER the day on January 18, 2022. I had an EKG and it showed an abnormal rhythm. It still happens occasionally but without the stabbing pain. I only feel the flutters.
Severe pain both arms. Limited range of motion. Went to Rheumatologist. It was determined to be chronic inflammation.
my tattoo flared up with a rash; very itchy and bumpy. It spread up my forearm to the inside of my elbow and also on my right forearm.; rash was bumpy; 16 days after the vaccine (04Mar2021) I still have redness; swelling; This is a spontaneous report from a contactable consumer (patient).   A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left arm on 16Feb2021 13:45 (at the age of 25-year old) as dose 1, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient has no known allergies. Prior vaccination, patient was not diagnosed with COVID-19 and did not receive any other vaccines within four weeks. After 2 days of receiving the vaccine, on 18Feb2021, his tattoo got flared up with a rash and was very itchy and bumpy. It spreads up to his forearm  to the inside elbow and also on right forearm.. At the time of report, that is, 16 days after the vaccine (04Mar2021, the patient still have redness and swelling, and is still itchy as well. Since vaccination, patient had not been tested for COVID. No treatment was received in response to the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a adult patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Flu vaccine. Additional details were reported as follows: The health care professional (HCP) reported that the patient had a history of an allergic reaction with a flu shot. The reporter didn't have any additional information to add to the report as he was inquiring on behalf of a friend. HCP was initially inquiring if any components of SHINGRIX vaccine would cause any reactions that flu vaccine would cause. No further information was available regarding the event.
This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with an improperly stored doses of ROTATEQ, oral (dose, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
After administration of shots on 8/29/01, pt experienced high fever, diarrhea, high-pitched screaming. 9/15/01-stopped breathing, cardiac arrest. 9/25/01-life support terminated. Pt died.
Information has been received from registered nurse (R.N.) for VARIVAX (Merck), a Pregnancy Registry Product, concerning a 16 year old female patient with no pertinent medical history and no drug reactions or allergies, who on 10-JAN-2012 was vaccinated with a dose of VARIVAX (Merck) (lot number 670249/0461AA (dose and route not reported), exp. date 31-MAR-2013. There was no concomitant medication. Registered nurse reported that on 10-JAN-2012, the patient who was pregnant received a dose of VARIVAX (Merck). Lab test included urine pregnancy test. LMP was 14-DEC-2011 and EDD is 19-SEP-2012. No adverse effect reported. Follow up information has been received from the registered nurse who reported that the patient never returned to the clinic for any care and had no information regarding her prenatal care or pregnancy outcome. Additional information is not expected.
Hemorrhage in right eye with pain behind the eye and in the eye itself. Looks very bloody, red and hurts. I had problems with my right shoulder after my 1st booster/3rd shot of Pfizer COVID-19 vaccine. Self-treating with eye drops and saline solution. Taking Tylenol for pain.
This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 48 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. on 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
A non-serious spontaneous report of gave full dose of H1N1 LAIV in one nostril was received from a registered nurse concerning a 11-year-old male. No relevant medical history was reported for this patient. On 18-Nov-2009 the patient inadvertently received 0.2ml of H1N1, Intranasal into a single nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
pt states the evening p/vx the site became red swollen;states site also began to itch;states went to MD & was told;had an allergic rxn to the Td;states took DPH & Ibuporfen for the rxn;states arm is better now;
A lot of itching - her ankles, the bottom of her feet and her neck area are the worse; Aching all over her body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (A lot of itching - her ankles, the bottom of her feet and her neck area are the worse) and MYALGIA (Aching all over her body) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PRURITUS (A lot of itching - her ankles, the bottom of her feet and her neck area are the worse) and MYALGIA (Aching all over her body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency; CETIRIZINE at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (A lot of itching - her ankles, the bottom of her feet and her neck area are the worse) and MYALGIA (Aching all over her body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Anaphylaxis or anaphylactic reaction started 5 to 10 minutes after injection. Sides, tonsil region and back of throat swelling. Duration of event 30 minutes. Pressure on right side of chest started approximately 4 hours after injection. Duration periodic over the next 13 hours.
Within 30 minutes of vaccination, the patient developed a fever and a whole body urticarial rash without respiratory distress. Medical attention was sought. The patient's symptoms resolved following treatment with Benadryl but for persistent left arm swelling. Within 24 hours of vaccination, the patient's symptoms were resolved. No further information is available.
Presented with 2 weeks SOB & cough; Admitted to medical with Covid PNA; tx with Velletri, steroids, Aviptadil, zinc, Actemra, Maxipime, flagyl; initially on HFO2, TX to ICU 9/25; intubated on 10/2/21; currently remains intubated with FiO2 75% and SpO2 holding >93%; no pressors; Renal function holding but precarious. She is on minimal amounts of Precedex and is planning for transfer to long-term acute care for vent weaning. She is doing some weaning on CPAP currently. Disposition: She will be discharged today to long term acute care.
Was in 1st trimester pregnant and began bleeding shortly after and ended up miscarrying approx 3 weeks later. Embryo stopped developing after shot
A non-serious spontaneous report of expired FLUMIST inadvertently administered was received from a registered nurse concerning a seven-year-old male. Neither medical history nor concomitant medications were provided. The patient received his first dose of FLUMIST on 11-Sep-2008. The FLUMIST had expired on 03-Apr-2008. The reporter stated that FLUMIST was given by one of the nurses helping out the clinic on 11-Sep-2008 and not by the nurse in-charge of immunizations. The incident regarding the expired FLUMIST was noted when the immunization record was being updated. As of 24-Sep-2008, there was no adverse event reported; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Mar-2009: Product Complaint Investigative results. Based on the results of the investigation, the root cause for the medication error were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 57 years old male patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for prophylaxis (dose, route, anatomical location, lot number and expiration date were not provided). On an unknown date in 2016, the patient experienced herpes zoster (shingles). As a direct and proximate result of the zoster Vaccine Live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The outcome of the event of shingles was considered as not recovered. The reporter considered the event to be related to zoster Vaccine Live (ZOSTAVAX).
Within 24 hrs, pain and swelling in left arm down to elbow.  Fatigue, overall muscle soreness and fever that have lasted two days.  Highest fever 100.9
Bumps at injection site; Injection site is itching really bad; Rash at injection site; Affected area like the size of medium bandage; Temperature of affected area is almost one degree higher than her forehead/Noticeable hot injected site; Red injected site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Temperature of affected area is almost one degree higher than her forehead/Noticeable hot injected site), VACCINATION SITE MASS (Bumps at injection site), VACCINATION SITE PRURITUS (Injection site is itching really bad), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Red injected site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Temperature of affected area is almost one degree higher than her forehead/Noticeable hot injected site) and VACCINATION SITE ERYTHEMA (Red injected site). On an unknown date, the patient experienced VACCINATION SITE MASS (Bumps at injection site), VACCINATION SITE PRURITUS (Injection site is itching really bad), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (Affected area like the size of medium bandage). On 18-Aug-2021, VACCINATION SITE ERYTHEMA (Red injected site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Temperature of affected area is almost one degree higher than her forehead/Noticeable hot injected site), VACCINATION SITE MASS (Bumps at injection site), VACCINATION SITE PRURITUS (Injection site is itching really bad), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (Affected area like the size of medium bandage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter.  Treatment information was not provided.  Patient stated that injection side has been red since the day, got the shot, the affected area looks like the size of a medium bandage, it is red and noticeable hot. Patient took the temperature of forehead and temperature of affected area, affected area was almost a degree above the temperature of forehead.  The affected area felt hot when put hand over it, even without touching it, patient can feel that it was hot. Inside the red line was a red rash, bumps that itches really bad. Patient has not been itching it and uses 90% rubbing alcohol for the affected area.  Patient had an appointment on 24-Sep-2021 not related to vaccine.
Patient death noted on 9/30/2021 - S/P SOB; Cause of death likely PE
Systemic: Dizziness / Lightheadness-Severe, Additional Details: Patient never lost consciousness just felt extremely dizzy and light headed.
Expired vaccine used for 2 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used for 2 days) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used for 2 days). On 09-Feb-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used for 2 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: The follow-up information received contain No new information (NNI).
I have been feeling pain in my legs, thighs, and buttocks. Every day it worsens, the pain is getting unbearable to the point where I am having difficulty walking let alone, jog or run. I cannot be seated for long periods of times either; my daily routines have been severely impacted by the use of this vaccine.
Within 24hrs after receiving the booster i began experiencing side effects.  They quickly became debilitating and remained so for 48hrs.  The side effects included lethargy, fever of 101°,  chills, headache, body aches, nausea, diarrhea, loss of appetite, and jaw pain.  The reason I am reporting this is because these were much more severe than than what I experienced after the 2nd dose but, according to any information I was able to access, there was nothing stating that booster side effects could be significantly worse than the 2nd does.  Additionally, there was no mention of the jaw pain.
Pt recvd vax 2DEC92 & exp burning when the vax was administered; 1 1/2 hrs following vax pt exp pain @ inject site & in most of lt upper arm, lt side of neck;
Information has been received from a registered nurse referring to an unspecified number of patients of unknown ages and gender. On unknown dates improperly stored doses of (Merck) VARIVAX (strength, lot#, dosage and frequency unspecified) were administered to the patients. No adverse effects were reported. Additional information has been requested.
When I am walk for in length of time, my breathing becomes labor. And it happens when there is hill.  I went to the doctor in July about it.  She send me for blood work and stress test.  I had a X-ray.  I am having a pulmonary test at the end of November and a CT scan in November as well. I also have to have more blood work done.
Patient had redness and swelling in right thigh.  Treated with Keflex.
This spontaneous report was received from a physician via a company representative concerning a 12 year old female patient. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose GARDASIL 9 (dose, route, lot# and the expiration date were not reported) for prophylaxis. There was no concomitant medication provided. The primary reporter stated one parent of one unspecified patient presented physician with media article stating that " a twelve year old girl died a couple hours after receiving GARDASIL 9, a separate patient was said to have entered premature menopause according to a Pediatrician, and a former company doctor reported that this vaccine was dangerous (unevaluable event)."  The cause of death was not provided by the reporter and it was unknown if the autopsy was performed at the reporting time. The outcome of premature menopause and unevaluable event was unknown. The reporter did not provide the causality between the events: premature menopause and unevaluable event and the suspect therapy. Upon internal review, death was determined to be medically significant.; Reported Cause(s) of Death: unknown cause of death.
This case was reported by a physician and described the occurrence of fever in an unspecified number of patients who received BEXSERO for prophylaxis. On an unknown date, the patients received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patients experienced fever, headache, malaise, myalgia, nausea and vomiting. On an unknown date, the outcome of the fever, headache, malaise, myalgia, nausea and vomiting were unknown.  It was unknown if the reporter considered the fever, headache, malaise, myalgia, nausea and vomiting to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not applicable to this report. The reporter had some questions about length of immunity and side effects. The reporter had a few patients in their last office with fairly severe reactions like high fever, headache (HA), malaise, myalgias, nausea or vomiting (N or V) after receiving BEXSERO. The reporter had patients most days.
Plaintiffs allege that as a result of vax (numerous manufacturers cited in litigation) @ age 4mo (born in 1957), plaintiff suffers severe neurological damage & is severely retarded.
This spontaneous report was received from a registered nurse and refers to a currently 16 years old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX subdermal injection, lot number N022980 with expiration date on 23-AUG-2019 (strength, dose and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 8 degrees F for 33 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
On the day after vaccinations @ 1pm in the afternoon (received her vaccines 4:30pm the day before), patient complained of backache, dizziness and headache.  Parent said she bumped into her brother and all of a sudden fell to the ground.  She started shaking and seemed to be "unconscious" (fainty).  She also vomited @ that time. She doesn't remember falling.  She was taken immediately to the local ER.  All tests @ ER were normal; "just slightly anemic"
NAUSEA. TOOK ZOFRAN AND STILL DIDN'T HELP. BONE HEAD NECK FEET EXTREME PAIN.
site of injection rash started 04/03 - itchy, small bumps progressing to larger site, hives, warm skin the round ring, lasting about week before getting better.
Severe fatigue; Headaches; Severe chills; Tachycardia; Adenopathy; This is a spontaneous report from a contactable consumer. This 31-year-old female consumer.  A 35-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Er8737, Expiration date: unknown), via unspecified route, administered in left arm on 08Apr2021 10:00 am (at the age of 35-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Er8727, Expiration date: unknown), via unspecified route, administered in left arm on 18Mar2021 at 10:00 am (at the age of 35-year-old) as DOSE 1, SINGLE for COVID-19 immunization from workplace clinic. The patient medical history and concomitant medications were not reported. No other vaccines administered in four weeks. No other medications administered in two weeks. Patient was not diagnosed with covid prior vaccination and was not tested for covid post vaccination. No allergies reported.  On 08Apr2021, after the vaccination, the patient experienced Severe fatigue, Headaches, Severe chills, Tachycardia and lymphadenopathy. Events resulted in healthcare professional office visit. Treatment was initiated with ibuprofen. The outcome of the events is recovering at the time of report.  No follow-up attempts possible. No further information expected.