chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was reported.
Pt reported that 15 min. to half hour after she received her shot she got a pain from front of Left chest, to shoulder, down arm to L elbow.  Then she felt like she was on something, her heart started racing and she felt like she was on something to speed her up.  She was shaking like she couldn't move fast enough.  Episode lasted about half an hour.  She later reported that the arm pain came and went for two or three days after.  Event was verbally reported to Health Dept and pt was sent to followup with Dr.
Hives formed around the injection site, had elevated BP, shaking, extreme itching, red blotchy skin.  Was sent to ER for evaluation and treatment. Received IV Benadryl, a dose of oral benadryl and IV fluids.
No additional AE PQC reported; temperature excursion PROQUAD were administered to 5 patients; This spontaneous report has been received from a physician assistant concerning to a 4-years-old child patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 11-AUG-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (route of administration, dose number and dose were not provided) (lot#: T034613, expiration date: 10-APR-2022) (product storage error) as prophylaxis. The total temperature excursion was above -15 degree Celsius (-5 degree Celsius) for a total time frame of 15 minutes. There were no previous temperature excursions. No additional adverse events were reported.  This case is one of six cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA004895: US-009507513-2108USA004894: US-009507513-2108USA004878: US-009507513-2108USA004896: US-009507513-2108USA004892:
Patient said a couple hours after the injection she started noticing some numbness in her left hand. The next day she also noticed that she was having what she described as tightness, throbbing, pain and numbness in her left leg as well. Patient said she has tried taking some aspirin and it did not relieve the pain. Told her to try taking some Tylenol to help with the pain and to monitor her symptoms closely and to seek medical attention if her symptoms do not start to improve by next morning or if they start to worsen.
I experienced lumps on my hands, fingertips red, welts on my body and legs. I went to see my doctor and he wrote me a prescription for some cortisone cream for the itching which helped a little bit but it still didn't relieve my symptoms. My doctor referred me to a Podiatrist who prescribed me a medication for the itching but it still has not relieved my symptoms. I'm scheduled to see the Podiatrist 08/12/2021 at 02:15PM for follow up.
The patient was to receive the booster dose of the Moderna COVID19 Vaccine. While being injected into the left deltoid, an unknown volume of vaccine leaked out of the syringe. At that time, the dose was not repeated. The patient was then contacted on 12/22/21 and notified that per CDC guidelines, she is eligible to have the booster dose repeated due to receiving an incomplete dosage. Patient stated that she has not experienced any adverse reaction and an appointment was made to repeat the booster dose on 12/27/21.
Patient is 11 years old but the 12+ year old Pfizer Bivalent Booster was administered.
experienced syncope following administration of GARDASIL 9; This spontaneous report was received from a physician via Company representative and refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 02-OCT-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscular injection (dose, anatomical location, lot # and expiration date were not reported) for human papillomavirus (HPV) prevention.  On the same day, after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient was advised to wait for 15 minutes, before leaving the clinic, but she decided to leave immediately. She experienced syncope when she got in her car to drive away, and went back inside the clinic. She was examined by the physician. It was unknown if any laboratory diagnostics or studies were performed. The patient recovered quickly on the same day without any treatment, and was able to go home without further event.  The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event of syncope was determined to be medically significant.
Received shots around 6:30 pm on 11/4/2010 at a routine physical appointment in the physician's office.  The next morning (11/5/10) at 7:45 am had a sudden onset of headache, neck pain and within an hour achiness all over body.  Took Tylenol 1000mg.  Shortly after, developed increased soreness, heat at injection sites with pain much greater on right arm to the point of not being able to lift right arm laterally.  By noon had chills and felt feverish and developed a "tickle" in chest causing coughing episodes (no thermometer to take temperature).  Took another Tylenol 1000mg.  By 6pm all symptoms had worsened, had rigors and coughing till gags.  Took more Tylenol.  By 7pm temperature was 102.4 degrees F.  Went to urgent care around 8:15pm.  Physician felt it was reaction to shots recommended rest, fluids, Ibuprofen 600mg alternating with Tylenol 1000mg every 3 hours, Benzonatate 200mg every 8 hours, and Tramadol 50 mg  every 4 hours.   Within an hour of visit developed intense nausea and unable to drink fluids.  Took Zofran 8mg during night and nausea improved.  Continued with high fever, severe head and neck pain, muscle pain and weakness all day 11/6/10 despite the treatment was unable to leave bed.  On morning of 11/7/10, fever was better, pain was present, but had improved.  That morning a large red area appeared on right arm about 3 inches below the injection site on Right upper arm.  Approximately 5 inches wide and 2 ½ inches high and warm to touch, and slightly raised.  No problems at all on the left side.  Fever and pain gradually got better throughout the day, but red area on right arm worsened and began to itch and hurt by 7pm on 11/7/10.  This trend continued throughout the day on 11/8/10 area was 7 inches wide by 5 ½ tall by evening located approximately in the middle of the upper arm between the shoulder and elbow.  The area was swollen, hot, painful, reddened with some areas purplish in color, slight itching especially on the underside of arm.  Went back to urgent care around 7:30 pm 11/8/10.  Physician diagnosed with cellulitis and prescribed Keflex 500mg tid for 10 days and Bactrim DS bid for 10 days which was started immediately.  The physician marked the area with marker and instructed patient to remark the edges each day and return if not receding in 3 days.  By evening of 11/10/10, the area looked much better.  Not as red, has not spread further, not hot, but continues to itch.  Will continue to monitor and return to physician if worsens.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 29-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  The date of vaccine refrigeration was reported as 07-May-2021.   This case was linked to MOD-2021-363765 (Patient Link).
Approximately 1hr after first dose symptoms began with the onset of a migraine center at the back of head. neck swelling and  angioedema diffused. Individual use Benadryl to manage symptoms. How ever swelling remained to the next day.
L arm became swollen & warm & painful 1 day 5 Kinrix. Pt. Rx'd Amoxil po, Motrin & cold compresses.
At 9:30p the hearing in my right ear suddenly went away followed by a low pitch ringing. It lasted about 20 seconds then stopped and my hearing returned. It happened again about 10 minutes later followed by a headache.
2-3 friends who have received their 2nd vaccine a month of so past the 6 month mark; This case was reported by a consumer and described the occurrence of drug dose administration interval too long in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis  Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: This case was reported by reporter who reported for friends. Age at vaccination was not applicable. The reporter had 2 to 3 friends who had received their 2nd vaccine a month or so past the 6-month mark, which led to lengthening of vaccination schedule. The reporter refused to provide any other details other than what was reported in this report. The reporter did not consent to follow up. This case is one of the 5 cases reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021097925:Same reporter US-GLAXOSMITHKLINE-US2021AMR099468:Same reporter US-GLAXOSMITHKLINE-US2021AMR099469:Same reporter US-GLAXOSMITHKLINE-US2021AMR099470:Same reporter US-GLAXOSMITHKLINE-US2021097926:
This case was reported by a physician via sales rep and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. The reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician stated that, the patient experienced fever (body temperature 101 degree F) for 2 days. The physician believed the fever was related to the SHINGRIX. The reporter agreed to be followed up. Lab Comments: On an unknown date, the patient's body temperature was recorded to be 101 degree F.
Immune mediated thrombocytopenia; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 68-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 4 (booster), single (Lot number: HF9275) at the age of 68 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "GERD" (unspecified if ongoing); "hiatal hernia" (unspecified if ongoing); "Nickel allergy" (unspecified if ongoing); "Known Allergies: Bee/Wasp Venom" (unspecified if ongoing); "Known Allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA taken for immunisation, start date: 16Sep2023, stop date: 16Sep2023; BENADRYL; PRILOSEC [OMEPRAZOLE MAGNESIUM]; VITAMIN D [COLECALCIFEROL] and Mens multi vitamin. Vaccination history included: Covid-19 vaccine (Primary series of immunization completed, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNE THROMBOCYTOPENIA (hospitalization, life threatening) with onset 01Oct2023, outcome "recovering", described as "Immune mediated thrombocytopenia". The event "immune mediated thrombocytopenia" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Oct2023) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of immune thrombocytopenia, patient was administered with steroids, IVIG, platelet transfusions.; Sender's Comments: Based on the available information, a possible contributory role of the suspect product cannot be completely excluded for the reported 'Immune mediated thrombocytopenia'' due to a plausible temporal association.The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
So I had general body pains and aches, headache, pain in the axilla, nausea, pain in my chest, fever of 101 for 24 hrs, fatigue, I was not hungry at all, the pain in the axilla lasted for a few days but the other symptoms went away in about 24 to 48 hours.
13 days after administration starting having swelling, redness and mild warmth around injection site. No fever, cough or pain. Sx are still persistent.
Head aches; migraines isolated in the back of head; This is a spontaneous report from a non-contactable consumer, the patient. A 24-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch/Lot number: unknown, Expiration date was not reported), via an unspecified route of administration on an unspecified date (at the age of 24-years-old) as a dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date, the patient experienced headaches and migraines isolated in the back of her head. The patient never had headaches like that before the vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headaches and migraines was not recovered at the time of this report.   No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Age at vaccination added as 24 years.
Patient administered 0.25ml booster dose for 2nd dose in primary series. Moderna called and recommended that (per CDC) patient be given 2nd half of dose same day. Patient notified and states she will return to clinic before end of business.
Fever from 2pm until about 2am. Next day felt OK. Day after that was fatigued with slowed brain function and mild headache. This lasted about 5 more days.
49 y/o female with past medical history of Thyroid Dysfunction who presents with dizziness post vaccination. Patient states that this is her first vaccination in the two-dose series. Patient denies previous reaction to vaccinations in the past. Patient states that she received her vaccination to the left arm. NP and Paramedics at patient side. Patient vitals within normal limits (133/82 BP, 83 HR, 12 Resp and 99% RA). Patient placed in Trendelenburg position and provided a bottle of water. Patient within 10 mins of observation states that symptoms have resolved. Patient states that she was nervous and scared of the needle. Patient stated that she wanted to go home. Patient able to ambulate without difficulty. Patient discharged in stable condition.
My thyroid went hyper 5 days after the first shot. I had high anxiety, and high blood pressure. The doctor said I had thyroiditis. Then 5 days after the second shot the same anxiety, and high blood pressure again. I am still being treated.
Aug90 pt vax hepta B. 3 dys after vax pt devel pruritic rash, joint pain, stiff neck, low-grade fever, and fatigue, cervical lymphadenopathy and elevated sedimentation rate.  MD made dx of serum sickness. TOR neck stiffness persisted.
Day 1: Fingertips numb & tingly Day 2: Vaginal area swollen & painful. Left labia very enlarged. Could not tell if the pain was from a bump(s) on the inner genitals or vaginal opening as area was so swollen. Extremely painful & sensitive to touch. Lasted several weeks. Bumps returned in Jan 2022 -painful & burning sensation. Day 5: Felt like wind was knocked out of her. Pain in mid area below chest. Day 15: Very shaky & jittery. Note: Same painful vaginal issues appeared 3 months after 2nd Pfizer vaccine shot.
Friday night - Sore arm and sore throat.  Saturday morning - Woke up sweaty. Swollen lymph node on right side of neck, close to collar bone. Very sore. As of today, Monday, 1/11, it is more swollen and hurts.  And I'm still having night sweats plus am extremely hot but not having a fever.
Patient reported that the vaccine injection site was red hot and feels hard. Appointment was not made for this.
Information has been received from a physician concerning a healthy 23 year old female health care worker with no pertinent medical history who in approximately 2006, was vaccinated with 2 doses of varicella virus vaccine live (Oka/Merck). In approximately 2007, the patient's IgG varicella titers were still negative. It was unknown whether medical attention was sought. The outcome was unknown. There was no product quality complaint. No further information is available.
4 days after the first shot I was feeling very very dizzy.   My ears felt full enough that I thought maybe they were just full of wax.  I bought an over the counter ear cleaning kit.  That didn't relieve any symptoms.  I never get headaches, but a couple days later the front top of my head was throbbing.  The area just above my forehead.  It was not sinus pressure, my face didn't feel any pressure or pain.  My throat also felt like I was being slightly choked.  Not my airway, but just my jugulars.  It began in the evenings.  It would feel like I had been hanging upside down for a while.  My head felt full of blood, like it was going to pop, like my eyes were bugging out.  By a week to 10 days later, my upper arms felt weak, my toes were tingling, and my heart would flutter for just a few seconds occasionally.  I was still dizzy, still felt like I was choking, except I was feeling this way all the time now.  The symptoms only seemed to be staying the same or getting worse.  I have NEVER gone to the doctor on my own in my life to get something checked, but this had me disconcerted enough to check in and see if I should get my second shot at all.  My appointment was to see my doctor was the morning of the same day I was scheduled to get my second Pfizer shot.  My doctor had not heard of these symptoms being associated with the Pfizer shot and chalked my symptoms up to stress.  I am not a stressful person and very much err on the side of "waiting to see what happens" if I feel sick.  I never feel sick.  But I accepted the explanation and took the second shot that day anyway.  It should be noted that the second shot made my left armpit swell up quite a bit.  I did feel dizzy again, but not nearly as much.  The other symptoms seemed to not be as bad either.
I developed a pain in my neck on the right side, joint pain, headache, and sorness in my left arm pit. Felt all of these symptoms as well as feeling crummy for 3 days
Having pins and needles in left hand, today having it in right hand as well, no treatment at this time still having symptoms this morning at time of report
Undiluted Pfizer Maroon Cap vaccine 0.2 ml was administered, No symptoms noted as of this date.
Onset red bumps right leg 5/21/2000, also feels warm - no temp taken, vomiting during night 5/21.
The day after in bed all day, achie body and head, ok the next day sweated at night the second night! Just was achie all day in bed and head ached next day fine!!!
Minor was in the observation area when he manifested dizziness and weakness in his legs. Mother indicates patient turned sweaty, pale, and cold. Patient was taken to the stretcher area, vital signs are taken, he was placed in the "anti-shock" position. Vital signs: -P-98 - SPO2 - 99 - B/P - 100/60 -R-24 - GCS - 15/15 After taking the Vital Signs and observing for 30 minutes, the patient indicates that he feels well. The mother is advised on possible causes of the event and post-vaccination care at home.
Patient had some sweats last night without chills. Felt 'unwell' yesterday but better today. Erythema 17 x7 cm at site of injection.
chills; fever; nausea; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache".  Additional information:  The patient stated that she was over 65-year-old and has received both doses of the Pfizer COVID-19 vaccine as well as the booster dose last Thursday and she has not felt any of the symptoms like she did after receiving the first two doses. She stated after the Second dose in April, she "really got hit with it" She stated, she had chills, fever, nausea, headache and she was wondering why she has not had much of a reaction this time other than a sore arm and she has been waiting for it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax;pain & erythema at site; no fever;T 98; WBC=7.4; pt pleasant; 2" erythema & tenderness at site w/ ? nodule;
Patient received a dose that had been diluted with sodium chloride by mistake. The new vials do not need dilution. Pt returned for another 1st dose.