chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    Concomitant medications details were not reported by the reporter.  Pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. The excursion was found out in an audit and all the vaccines were viable.  Treatment details were not reported by the reporter.
short red line and but it didn't feel like nothing it was just a red line there and then the patient woke up yesterday morning and it was burning; swelled up; Subcutaneous; red line going down collarbone; This is a spontaneous report from a contactable consumer (patient). A 63-years-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), subcutaneous in right arm on 29Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had first Pfizer COVID-19 shot (COVID-19 Vaccine), the 29Mar2021 two days ago (reported on 31Mar2021). The patient had nothing on collarbone when the patient went there and got the shot, the patient got the shot on right arm and when the patient got home the patient just had this red line going down collarbone, the short red line and but it didn't feel like nothing it was just a red line there and then the patient woke up yesterday morning and it was burning and yesterday afternoon it turn around and it swelled up and it like had a 'gas down' (not clarified) as it was seen where the red line was and it looked like it's coming down affected, so the patient put on (not clear nor clarified). It's still swollen on right side, they did right arm where the vaccine was and then it's right collarbone. It was on collarbone and now it looks like it's just an infected area, it was all puffed up and everything else (not clarified further). Outcome of the event swollen was not recovered, of other events was unknown.  No follow-up attempts are needed. No further information is expected.
Pt reported he did not have any trouble with the 1st vaccine.  He states he had the 2nd Shingrix yesterday and the next day at work he felt lightheaded then broke out in a sweat for about a half hour.  He stated that he kept feeling like he was going to pass out.  He went home and laid down, he did start to fell better, just felt weak.
Received vaccine, within 10 minutes developed a red rash on neck with small hive. Given benadryl, improved within 30 minutes.
Patient requested bivalent Web Iz was not available and patient's card did not show bivalent
patient vaccinated with Moderna that expired on 8/11/2021.  Moderna vials were moved from Freezer to fridge on 7/12/2021
Case number PHEH2011US04984 is an initial spontaneous report received from a nurse on 22 Sep 2011. This case refers to an adult patient of unknown gender. The patient was received only the MenA lyophilized conjugated component of MENVEO vaccine (batch number: M100034) that were reconstituted with a sterile diluent, intramuscularly on unspecified date. No adverse reaction had occurred following this drug administration error.
I had the expected low grade fever and body pains as with the first vaccine. On the following Friday, I had a huge fever blister on my lower right lip. I have NEVER had a fever blister in my life before. My lips cracked and all the skin shed on my lips by the following Sunday.
Within 2 hours of receiving my covid booster I developed several severe HSV ?cold sores? on my lip/mouth. They worsened over 2 days. They are now starting to heal.  No other symptoms other than mild to moderate pain and swelling at injection site.
Patient has not sought treatment.  Within 24 hours of second dose of vaccine being administered she experienced body aches all over that were significant but not debilitating, pain and swelling in the right arm at the site of injection, and developed a temperature of 101.2 F.  Using over the counter medication to mitigate higher temperature.
This is a spontaneous report from a Pfizer-sponsored program, Xeljanz Program from a contactable nurse and a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ XR) 11mg, via an unspecified route of administration from Dec2020 and ongoing (Lot Number: EH9982) at 11 mg for an unspecified indication. Medical history and concomitant medications were not reported. On an unspecified date patient experienced lightheadedness, tired, overheating and breaking out in sweat. On 16Apr2021 she felt like throwing up and fainted. Patient reported experiencing lightheadedness, really tired and felt like overheating and breaking out in sweat. Patient also reported a month and a half before the time of the report, on 16Apr2021, she felt like throwing up and fainted. Patient also took the covid-19 vaccine and held the medication for two weeks. No further information provided. The action taken in response to the events for tofacitinib citrate was unknown. Outcome of the events was unknown.  The information on the batch number has been requested.; Sender's Comments: Assuming a plausible temporal association,  a contributory role of BNT162B2 vaccine and tofacitinib citrate for syncope cannot be completely excluded. The event seems to be the result of a vagal reaction.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Initial information was received on 20 August 2009 from a health care professional.  A 15 year old female patient with a history of hypothyroidism (being treated with SYNTHROID), obese, hypertriglycerides, impaired fasting glucose experienced a reaction after she received ADACEL (lot number C2572AA) on 16 August 2007.  On 16 August 2007, 30 minutes post vaccination the patient developed severe pain in both legs and was unable to move her legs which lasted 15 minutes.  The patient was not seen by a health care professional but was given instruction over the phone.  No further information was provided.  Follow up information received on 02 October 2009 from a health care professional who reported that the patient did not have an illness at the time of vaccination.  The patient did not receive prior doses of ADACEL.  The lot number for GARDASIL which was administered was reported as 0188U.  Treatment was not provided for the patient's symptoms.  No further information was provided.  Follow-up information received on 09 November from a health care professional who reported that no additional information was available on this case.  List of Documents held by Sender: none.
Information has been received from a 20 year old female who on 07-MAR-2007 was vaccinated intramuscularly with 0.5 ml dose of Gardasil. Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO-CYCLEN). On 09-MAR-2007, the patient's right lymph node swelled to the size of a marble. She sought unspecified medical attention. The patient reported that she recovered 1 1/2 weeks after the swelling began. On an unspecified date, the patient was vaccinated intramuscularly with 0.5 ml of the second dose of Gardasil. Two days after the vaccination, the patient's left lymph node swelled to the size of a marble. The patient sought unspecified medical attention. Additional information is not expected.
Shortness of breath, tachycardia, chills, minor muscle aches, nausea, head ache
very tired 48 hours after red itchy blotch appeared exactly one week after the injection at the site. Disappeared 24 hours later.
Mild Fever around 6-7pm, tachycardia, chest pain. For about 10-15 mins. Thought I was going to die so I took a nap. Woke up chest pain gone, heart rate lowered, fever gone after 6-7 hours
Information has been received from a physician concerning a 16 year old female patient who on 24-APR-2007 was vaccinated with her first dose of Gardasil, lot # 657006/0188U. After receiving the first dose, she experienced amenorrhea. Unspecified medical attention was sought. Her outcome was unknown. Additional information has been requested.
Unresponsive eipsode approx 30 minutes.  Slurred speech, facial droop, aphasia, headache
Information has been received from a registered nurse concerning a 22 year old female with a history of tonsillectomy and wisdom teeth removal and no drug reactions or allergies who on 17-JUL-2007 was vaccinated with a first dose of Gardasil (lot # 0469U) one pre-filled syringe IM. Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). On 17-JUL-2007 3 hours after the patient was vaccinated with Gardasil the patient developed a rash. The rash was approximately 200 lesions that "looked like acne" at the injection site of the right deltoid and spread to the patient's back, chest and right breast. There were no lesions on the left arm. Medical attention was sought. The patient took diphenhydramine hydrochloride (BENADRYL) for a complaint of slight itching to the lesions. After the patient's second dose of diphenhydramine hydrochloride (BENADRYL) the patient stated that the rash "got a little better". At  the time of reporting the patient was still recovering. No additional information was available. Additional information has been requested.
36 hours after the vaccine, I don't know if it was the vaccine or what, but I had BODY PAIN CHILLS AND FEVER OF 99.08  FOR A DAY OF FEVER. FROM MARCH 15 TO MARCH 16. AND FOR THREE NIGHTS IN A ROW I AM SWEATING A LOT OF WET MY T-SHIRTS AFTER SLEEPING 2 OR 3 HOURS I CHANGE THEM FROM 3 TO 4 TIMES AT NIGHT, IT IS ONLY AT NIGHT NOT IN THE DAY, I NEVER SLEEP IN THE DAY. I'M CONCERNED BECAUSE I HAVE AN APPOINTMENT FOR 03/04/2021
mildly dizzy; heart palpitations; This is a spontaneous report from a non-contactable consumer (patient). A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0161), via an unspecified route of administration in the left arm, on 26Apr2021 at 10:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or known allergies. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included estradiol (ESTROGEN) (reported as low dose), acetylsalicylic acid (BABY ASPIRIN), and omeprazole (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: ER8734), in the left arm, on 05Apr2021 at 10:15 (at the age of 51-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced heart palpitations on 26Apr2021 at 10:35 and mildly dizzy on 26Apr2021 at 10:40, which were reported as serious and medically significant. The clinical course was reported as: The patient experienced heart palpitations five minutes after receiving the vaccine, which went on for three minutes. Then, five minute later, she got mildly dizzy and was then fine for 10 minutes. This was reported to have repeated this cycle for two hours. The patient did not receive any treatment as a result of the events. The clinical outcome of heart palpitations and mildly dizzy was recovered on 26Apr2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Extreme soreness of arm, painful to touch, difficulty breathing because of chest pain, joint pain in left shoulder joint
Resident began experiencing pain in her left upper arm on 2/16/2021. Arm has been red, warm, and swollen from approximately 3 inches above elbow to 1 inch below shoulder. Some bruising to area as well.
24 hours after the vaccine I developed a sharp pain on the inside of my left knee, slightly above the knee cap.  There was a soft bump in that area.  At work the next day I felt more sharp pains and bumps developing around my knees on both legs. The backs of my thighs were also beginning to burn.  I contacted the hotline set up at my work for adverse reactions when I got home from work that night.  They were concerned and had me call my doctor.  My work is onboard an aircraft and she did not want me to fly again without an ultrasound. I had an ultrasound perform on my left leg and the thigh of my right leg. It was normal.  Over the next week I would get stinging , painful bumps and used NSAIDS to help. Approximately six days after the shot the burning sensation on my thighs got worst. It spread for the back of my thighs to the front and then to the calves, arms and shoulders in that order, I started taking Benadryl to release the burning. I went to my doctor who sent me for another ultrasound and blood up. Three weeks after the injection the painful stinging bumps are still happening and the burning is on my legs, arms and shoulders. I am going back to the doctor today and talk about prescribing Gabapentin.
Pt recvd vax on 22MAY92, 24 hrs later devel hives on neck & tightening of throat; pt recvd 2nd dose of vax & w/in 30 mins throat got dry & felt tight; seen by MD but not meds was administered for exp;
Patient waiting in observation for 15 min. 10 minutes into waiting patient waves down field ops  who caught patient in chair from falling. Observation nurse and charge notified. Vitals taken. 119/76, 98% o2, 76 pulse,  96.7 temp RR 20, lung sounds clear. Patient stated she felt sweaty and had blurry vision and decided to call for help. Patient asked to wait 30 min. Patient on floor, legs elevated, conscious and able to communicate. Mother came to assist. Patient sat up on floor and able to tolerate water. Vitals rechecked and stable. Vitals reassessed before leaving site 100/63, pulse 90, O2 97%,  RR 18, temp 97.6. Patient states she feels much better and tolerates standing.  Edicated to seek medical attention if symptoms return or worsen. Patient accompanied by mother and nurse to car without incident at 4:05 pm.
This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm is really red), DECREASED APPETITE (no appetite), HEADACHE (severe headache), CHILLS (body chills) and ARTHRALGIA (joint hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (arm is really red), DECREASED APPETITE (no appetite), HEADACHE (severe headache), CHILLS (body chills), ARTHRALGIA (joint hurts) and NAUSEA (nauseated). At the time of the report, ERYTHEMA (arm is really red), DECREASED APPETITE (no appetite), HEADACHE (severe headache), CHILLS (body chills), ARTHRALGIA (joint hurts) and NAUSEA (nauseated) outcome was unknown. Concomitant medications were not provided. Treatment information was not reported. This case was linked to MOD-2021-190647.
welts just below the injection site (distal to site), fatigue, stiff neck, headache, fogginess   This is first day of symptoms - have progressively worsened through the day
Client administered Pfizer Booster shot; however, it has not been at least 6 months since receiving his second dose.  he does not have any underlying medical conditions nor is he immunocompromised.  Client advised that he does not need to repeat the dose even though it was given 3 months early.  Client departed with no s/s adverse reaction.
Low grade fever and extreme drowsiness. I slept for 12 hours straight after 2nd shot at 4:30 pm the day prior and  a difficult day at work!
This spontaneous report has been received from a physician concerning a patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On 22-JUN-2015, the patient was vaccinated with an improperly dose of GARDASIL (lot # K009482, exp. date on 06-MAR-2017), (strength, route of administration and dose were not provided). No adverse symptoms were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
A consumer report has been received. The report concerns a 13 year old, Female consumer, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced RUNNY NOSE, WATERY EYES, HEAD COLD and CONGESTION which started on 01-Oct-2013. At the time of reporting, the event of RUNNY NOSE, WATERY EYES, HEAD COLD and CONGESTION was ongoing. The report was considered to be non-serious.
Fever 103, pronounced redness, heat, hard at injection site lethargic x 3 days followed by 7 day high-pitch screaming withdrawal, loss eye contact, persistent diarrhea, sleep disturbances, restlessness, flopping.
2 days after receiving Kinrix vaccine broke out in bright red spots on palms and sole only.  Rash resolved within 24 hour.
adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse reaction). At the time of the report, VACCINATION COMPLICATION (adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.
My arm was throbbing with pain down into my hands.  I could hardly lift my arm and could not sleep the first night.   I had fever of 100.3, headache, rapid heart beat and joint pain throughout the night.    Off and on, I iced my arm for hours.  I finally took extra strength tylenol 23 hrs after the injection.  It helped but my fever persisted until Tuesday, March 9th along with headache and arm pain.  On the evening of March 9, i developed a huge red, warm rash all over my upper arm below  the injection site.  It is more than half way around my arm and about 3-4 inches long.  I rubbed benedryl on it and took a Benedryl pill.  It still appears on my arm and is warm and tender on the morning of March 11th.
COVID+ 1/2/23.  Vaccination Status - moderna x4 + Pfizer BIVALENT x1 BRIEF OVERVIEW: Discharge Provider: MD, MPH Primary Care Physician at Discharge: DO  Admission Date: 1/2/2023 Active Hospital Problems   Diagnosis Date Noted POA ? COVID-19 virus infection 01/03/2023 Unknown ? Tachypnea 01/02/2023 Yes ? COVID-19   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Tachypnea  Acute respiratory failure, unspecified whether with hypoxia or hypercapnia  COVID-19 virus infection HOSPITAL COURSE: 89-year-old woman recently admitted for hypoxic and hypercapnic respiratory failure secondary to aspiration pneumonitis.  She completed aspiration coverage with Unasyn and was weaned back to her baseline 2 L of oxygen and discharged to her facility.  She came back COVID 19 positive with worsening respiratory failure and family elected to make patient comfort care / hospice.  Family did not want to pursue aggressive measures and opted for comfort measures.  Spectrum Health hospice was consulted and managing patient's symptoms.  Due to decline in patient's clinical condition, she was made GIP Hospice and Hospice team helped manage patient's symptoms. Patient eventually passes away. Patient's son was at bedside when patient passed away.  Medical Examiner Case Assessment Select Applicable Patient Criteria: Does not meet any of the listed criteria
Two weeks after receiving my second dose of the Pfizer vaccine I began to have an urgency to pee that I thought was a UTI. There was no smell, no urine discoloration, but a consistent urge to pee even right after having used the bathroom and especially at night. I went to the doctor twice and did two rounds of antibiotics but no UTI was detected (also all tests for STIs came back negative).  The doctors did not see any evidence of infection.  After talking with friends, multiple women all in the 30-40 age bracket have reported similar symptoms.