chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My joint pain the first night was debilitatingly severe and I spiked a fever which finally broke overnight that Saturday.  I was drinking lots of fluids, so when I started peeing more than usual on Saturday I didn't think much of it.  It got worse on Sunday, but there was no pain.  The pain finally started today, along with a little blood.  I went to the doctor and the test confirmed I have a UTI.  There are red and white blood cells in my urine, and the hyaline casts were high enough that it flagged them too.  Normally, I would not have reported this but the timing was very strange and based on the severity of my joint pain the night of, it is not just a weird coincidence.  I was not experiencing any urinary symptoms before the vaccine. I found that there have been others during the study who experienced UTI's following vaccination with the Moderna and Pfizer vaccines and although the study determined no correlation, I thought it important to report it. With me, for reasons no one seems to understand, my kidneys react to my allergens before anything else does. I'm assuming that is why I am having the UTI issue right now, although no bacteria got flagged in my sample.
Vial expired on 13-May-2022 was palced in refrigerator on 17-May-2022 and then administered on 19-May-2022; Dose administered post the expiration or beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vial expired on 13-May-2022 was palced in refrigerator on 17-May-2022 and then administered on 19-May-2022) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 013F21A, 011M20A and 032H20A) for COVID-19 prophylaxis.     The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Blood pressure high.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 19-May-2022 at 10:10 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 19-May-2022 at 10:10 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 13-May-2022 was palced in refrigerator on 17-May-2022 and then administered on 19-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vial expired on 13-May-2022 was palced in refrigerator on 17-May-2022 and then administered on 19-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial expired on 13-May-2022 was palced in refrigerator on 17-May-2022 and then administered on 19-May-2022).    No concomitant medications were reported.  The health care professional thought that Moderna had an extension like Pfizer, and though it would expire on the 13-Jul-2022 but it was expired on the 13-May-2022 and they realized that on the 08-Jun-2022.  The vial was placed in refrigerator on 17-May-2022.   Vials did not undergo any temperature excursion.  The event did not cause patient to seek medical care. The reporter did not report any other potential causes.   No treatment information was reported.   This case was linked to PR-MODERNATX, INC.-MOD-2022-585601 (Linked Report).; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-585601:Master case
Red streak growing down the arm as far as the wrist, painful, swollen, taking pain meds. Seven days later worse, thick red streaks looking like expanded veins.
Soreness, increasing warmth. After a few days it looked like bug bite swelling and was getting worse. Took Benadryl to try and stop reaction.
Chills, overall body aches, headache, nausea, vomiting (one episode), fatigue. First side-effects noticed about 15 hours after vaccination (vaccination was Wednesday morning; first symptoms mid-night that night). Spent one full day in bed with side-effects (Thursday). Appear to have fully recovered by following day (Friday). I had no negative reactions to first dose of Shingrix administered on 11/04/2020. Only medication taken during side-effects was Acetaminophen.
Shortness of breath, bodyaches.  Treated with TORADOL IM & ALBUTEROL NEBULIZER X 2.  Symptoms started around 1800.
Pt reports 10 minutes after injection, tightness in throat. Pt speaking in clear and full sentences, able to swallow water but continues to clear throat.
I just had like a head cold with drainage, coughing, sneezing, congestion and runny nose. I also had a bitter taste in my mouth. I went to urgent care and started taking PAXLOVID. I am feeling completely better today.
2 HOUR AFTER VACCINE EMPLOYEE DEVOLOPED RASH ON LEGS AND ARMS  PERSISTED UNTIL ATLEAST 1/14/20201, MAY STILL BE ON GOING.
Neuropathy in left neck, shoulder, arm, and hand.  Numbness, pain, and reduced mobility in all cited areas
Itchiness started on site of injection than entire body became itchy within hours after. Small bumps all over the body plus itchiness
This spontaneous report as received from a medical assistant/healthcare worker refers to a patient of unknown demographics. On 13-NOV-2015, the patient was inadvertently administered an expired dose of PNEUMOVAX 23 (Lot#K007824 and expiry date: 05-NOV-2015). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
An ASSP was received from a regulatory authority on 10/29/00, concerning a 40 year old female patient who experienced a metallic taste at the back of her mouth and a tingling sensation on the tip of the tongue which was considered to be medically significant after receiving the Fluvirin vaccine on 10/10/02. The patient has a medical history, a penicillin allergy and an allergic reaction to aspirin. The patient was also received solpadol concomitantly. On 10/10/02, 10-20 seconds after the vaccination, the patient complained of a metallic taste at the back of the mouth and tingling sensation on the tip of her tongue. There as insufficient information to determine the reporter's causality assessment. The reporter considered the metallic taste and tingling sensation to be medically significant as further immunization could cause problems.
No known vaccine adverse reactions; parents report father rolled over on infant found unresponsive per mother; preliminary autopsy: asphyxiation per suffocation.
two other adverse events; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (two other adverse events) and MYALGIA (muscle aches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On an unknown date, the patient experienced UNEVALUABLE EVENT (two other adverse events) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia, at a dose of 1 dosage form. At the time of the report, UNEVALUABLE EVENT (two other adverse events) and MYALGIA (muscle aches) had resolved.            No concomitant information was reported.   Reporter did not allow further contact
30 minutes after injection patient experienced flushing of face, sweaty palms and shakiness, jaw tightness and nose tingling, heart felt like it was racing. Blood pressure was 150/80 , Pulse 108, respirations 22
sore left deltoid; mild muscle aches; mild neck/joint pain; mild neck/joint pain; tired; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL1283), via an unspecified route of administration in the left deltoid, on 09Jan2021 (at the age of 41-years-old) at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and COVID-19. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included amlodipine besilate (NORVASC), ascorbic acid (vitamin C; MANUFACTURER UNKNOWN), ergocalciferol (reported as: vitamin D; MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), and magnesium (MANUFACTURER UNKNOWN). Other concomitant medications included unspecified daily multivitamins (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), intramuscularly in left arm, on 19Dec2020 at 07:00 (at the age of 41-years-old) for COVID-19 immunization and experienced sore left deltoid (Day 1), body aches (Day 1), headache (HA) (Day 1, 2, & 3), all over body aches (Day 2), fatigue (Day 2, 3, & 4), chills (Day 2), myalgia/muscle ache (Day 3), all over joint pain (Day 3), lower/upper extremity (LUE) pain (Day 4), and muscle and bone pain (Day 4).  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced sore left deltoid, mild muscle aches, mild neck/joint pain, and tired on 09Jan2021. The events were reported as non-serious. The events occurred on day 1 after vaccination and by day 2, the patient felt great with no side effects. Therapeutic measures were taken as a result of all of the events, which included paracetamol (TYLENOL) and ibuprofen (MOTRIN). The clinical outcome of sore left deltoid, mild muscle aches, mild neck/joint pain, and tired was recovered on 10Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
p/vax 12JUL96 pt had screaming episodes on & off for 2wk per mom;
In the evening on the day the vaccines were administered patient spiked a time of 103.1 rectal.  He also had vomiting and diarrhea for approx. 3-4 days following the vaccination.
pain from top to bottom of her body; couldn't lift right leg; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received 2nd single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: Ew0217, expiration date unknown) via an unspecified route of administration in the arm left on 30Jun2021 at 12:00 PM at age of 81-year-old for COVID-19 immunisation. Patient was not pregnant at time of vaccination and events onset. Medical history included blood pressure high (Hbp) and diabetes. Patient previously received 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EW0186, expiration date unknown) in the left arm on 08Jun2021 at 12:00 PM at age of 81-year-old for COVID-19 Immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was reported as monthly prescriptions. Patient reported pain from top to bottom of her body to the point she was having trouble concentrating on anything but her pain. Patient couldn't lift right leg and Tylenol and ibuprofen were not making it go away. Adverse events start date was 01Jul2021. Adverse events start time was 07:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and disability or permanent damage. Outcome of the events was not recovered. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 by Nasal Swab on 08Jul2021 which was negative.
High fever for several days after injection, nausea, headache, joint ache, fast hear rate, muscle aches, sustained perception/cognition challenges.
shots were given @ approx 1045AM pt's mom notified PHN by phone 11MA; pt became nauseated, eyes rolled back in head & fell to the pavement hitting head; arms & legs were jerking. When pt. came to vomited and did not remember passing out;
Thursday - pt reports fever, chills, body ache. arm swelling  local. took tylenol, slightly painful to the touch and hot to the touch.
bilateral shoulder pain/iliac crest pain started 3 weeks after 2nd COVID-19 vaccine.  Noted to have elevated ESR (47).  Symptoms improved immediately after starting prednisone.  Suspect polymyalgia rheumatica -- ?vaccine related.
I initially had pain in left shoulder, some chills and light headiness. Those dissipated by the second day. But 5 days later I developed a hematoma in my left bicep. It was like someone punched my arm as it was purple and red. Within a few weeks it turned to a brown and yellow and currently no coloring. However, my shoulder is tight and some pain and my bicep is experiencing tightness and pain. The Dr who administered the shot was not wearing gloves and injected the vaccine towards the rear of the shoulder and caused me to bleed. I usually coagulate well.  My shoulder has discomfort and when moved side to side has a crackling and clicking.  I had Torn labrum surgery approximately 4 years ago.
Fever; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC number and UPC number: not reported), via an unspecified route of administration on 20Mar2021 at 11:00 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever on 21Mar2021. Reporter stated that the patient had the vaccine on 20Mar2021, Saturday at approximately 11:00 am. It was fine and then in the afternoon of 21Mar2021, fever started spiking and at that night of 22Mar2021 it was 103.5. It really worried him. His concern was that, at 08:15 it was coming out as 101.7. It was coming up so they gave him three Advil, Ibuprofen. And it climbed when they just checked it a few minutes ago. So, they wanted to know why was it not responding to the fever reduce and What else could the reporter gave him to get the fever come down because the fever was going up. Reporter stated that the patient took it at 8. By then, it should have kicked in and then at 10:13, his fever was a 103.5 and it might have not worked from 101.7 at 08:15 up to the groove. The reporter meant a lot in 2 hours. The reporter gave him Advil, you could not give him more. But it did not respond to the fever. What could the reporter give him to reduce his fever. Reporter was informed about the role of Pfizer drug safety. Reporter gave him Advil more but it did not response to the fever reduce. Reporter asked what could the reporter give him to reduce fever. Reporter asked whether you could not give the reporter an answer at that time. Reporter asked whether it was the emergency contact number. The patient underwent lab tests and procedures which included body temperature: 101.7 on 22Mar2021 at 08:15 (fever), body temperature: 103.5 on 22Mar2021 at 10:13 (fever at night). Therapeutic measures were taken as a result of fever. The outcome of event was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
injection site hardness/sore; Aches and pain; Nausea; Headache; Feels like has a temperature; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches and pain), NAUSEA (Nausea), HEADACHE (Headache), PYREXIA (Feels like has a temperature) and VACCINATION SITE PAIN (injection site hardness/sore) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive (Late October/early November).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced MYALGIA (Aches and pain), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Feels like has a temperature). On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (injection site hardness/sore). At the time of the report, MYALGIA (Aches and pain), NAUSEA (Nausea), HEADACHE (Headache), PYREXIA (Feels like has a temperature) and VACCINATION SITE PAIN (injection site hardness/sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.
THROMBOSIS of the splenic vein and superior mesenteric vein, acute necrotizing pancreatitis with 8 cm cyst formation
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 76 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 08-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 08-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no other medication in 2 weeks. The patient received therapy with anti viral product Oral Paxlovid for COVID 19 Treatment, which was started on 29Sep2022 and stopped on 04Oct2022. AE treatment with tylenol, ibuprofen, electrolytes. The patient had no Known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal association of suspect  drug  BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5),BNT162b2 cannot be excluded for reported events-Drug ineffective and COVID-19
received 2 doses of Moderna COVID-19 vaccine one after another one; A spontaneous report was received from a nurse concerning a 59-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced: received two doses of Moderna COVID-19 vaccine, one after another one by mistake (extra dose administered).   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter   On 11 Mar 2021, the patient presented to receive her first dose of two planned doses of the Moderna COVID-19 Vaccine (mRNA-1273, lot number: 029A21A, expiration: 22 May 2021). The patient ended up receiving two doses of the vaccine (one after another one) by mistake via intramuscular injection into the right arm.  At the time of the report, the reporter stated the patient was currently in an ambulance on site being monitored.   No treatment information was provided/was unknown by the reporter.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, received two doses of Moderna COVID-19 vaccine one after another one by mistake  (extra dose administered), was considered resolved.  Causality was not provided by the reporter.; Reporter's Comments: This report refers to a case of extra dose administered for mRNA-1273, lot # 029A21A with no associated AEs
Post vax, the pt complains of having knots on right arm. Pt is complaining also of muscle cramping/spasm.
On 10/01/19, the donor reported that the day after receiving a previous Rabies vaccination (3/8/19) she experienced a back spasm.  She also experienced spasms two more times and did not recall the dates.
pt recvd vax & exp fever & hives 10 days p/1st inject;
Patient experienced swelling in elbow and shoulder joint of left arm.  Patient also reported having chills.
Extreme erythema and edema across entire Left shoulder, approx. 5 inches from shoulder joint, 3 1/2 x 2 1/2, with extreme itching.  It was reported that small amount of redness at injection site  was noted 2 days after the injection, that later resolved, and noted itching at the site on 01/03/2021, and noted the extreme redness, with increased itching on early morning of 01/06/2021 at 4:40am. MD appointment is pending.
When I got the vaccine, I started having intense migraines after getting the vaccine. I didn't think much of it until 24 hours, I started having spinning episodes. It happened every 5 minutes or so, and then began happening 2-3 times a week, normal signs of vertigo. I would have to sit down and let it pass because it wouldn't go away by resting. Nausea eventually accompanied it as well as having hot flashes. I contacted my neurologist and informed them about it; because availability is low, I'm finally going in for another check up soon.
My arm became swollen and sore to the touch at the injection site within the first hour. With in 2-3hrs my arm was so sore I could hardly lift it to shoulder height or rotate it.  It was way more severe then I have ever felt from a standard vaxx or flu vaxx in years past. That continued for a full 48hrs, after that it subsided but was still sore around the injection site and the muscle.  I was able to typically use the arm again with minimal pain. Around 14-16hrs after the injection I began to feel very achy and sick. My shoulders, neck and head hurt. I did not have a fever, but my skin all over my body was achy to the touch as well. I also found my self to he extremely tired, like feeling run down, around 12hrs after the shot (when I woke up). The ?fluish? feeling of a headache,  feeling achy and being tired did get a little better but has continued into the 3rd day (today when I am reporting this).