chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race, and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On 07-APR-2021, the patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, (Dose number in series 1), 1 in total, for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 16-DEC-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) positive. On an unspecified date, following vaccination with covid-19 vaccine, the patient experienced mild case with congestion, headache, mild fever (confirmed covid-19 infection) and confirmed clinical vaccination failure (dose number in series 1). The action taken with covid-19 vaccine was not applicable. The patient did not recover from confirmed covid-19 infection. The outcome of the confirmed clinical vaccination failure was unknown. On 25-OCT-2021, the patient received booster dose non-company vaccine mRNA 1273 (form of admin, route of admin, and batch number were not reported) dose was not reported (dose number in series 2), for prophylactic vaccination. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000207466.; Sender's Comments: V0: 20211237695-covid-19 vaccine confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
I received my first Pfizer booster for COVID-19 on 10/22/2021. On 7/19/2022, I experienced fatigue and fever, which was about 99 degrees. I was out of town when I began having symptoms. These symptoms continued as I flew home on 7/21/2022, and I just slept through the flight. On 7/22/2022, my fever climbed to about 101 degrees, and I began having body aches. On 7/24/2022, I took a home test for COVID-19, and the result was positive. I called my doctor's office and spoke to a nurse, and I was advised to take OTC pain relievers, drink plenty of water, and ride it out. I alternated between taking Advil and Tylenol about every 6 hours to treat my symptoms, and they helped keep my fever in check and helped relieve some of the body aches. The symptoms continued until about 7/26/2022, and my fever stabilized at about 99 degrees. The body aches went away, though I still had some residual fatigue. In the meantime, I worked from home on 7/28/2022 and 7/29/2022. I then finally came out of isolation on 8/1/2022 and returned to the office. At the time of this writing, I feel fine and I have fully recovered from the breakthrough.
Information has been received on 23-MAR-2018 from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 10-OCT-2015, the patient was inoculated with the ZOSTAVAX (lot number and expiration unknown) unknown route, administered by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 26-APR-2016, the patient was treated by a physician and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report was received from a physician concerning her 85 year old mother with dementia, congestive heart failure and a shunt in her brain, who on 04-FEB-2014 was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. Concomitant medications were not reported. The physician reported that her mother's dementia progressed after receiving ZOSTAVAX. She also reported that her mother was eating slower and also walking slower after ZOSTAVAX was given. The patient did not seek medical attention. At the time of the report, the patient was recovering from the event. Additional information has been requested.
Did not get 2nd dose 1 month after the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get 2nd dose 1 month after the 1st dose) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 11-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get 2nd dose 1 month after the 1st dose). On 11-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get 2nd dose 1 month after the 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.
Information has been received from a health professional concerning a 29 year old female who on 05/24/2001 was vaccinated with one dose of varicella vaccine. Two weeks later, on approximately 06/07/2001, the pt sought medical attention and presented with bumps around the injection site and her arm was swollen and sore. She was thought to have a possible cellulitis. A few days later, the pt developed chicken pox, with most of the lesions on her arms and some on her back and chest. She is unaware of any exposure to wild chicken pox. Additional info has been requested.
Woke up 2 days after receiving my booster shot with a baseball size lump under my left armpit which was sore and hard to the touch. It was gone by the morning of the third day. Please note: my niece had the exact same reaction in the same place (armpit of injection site) but received her booster at a different facility.
On 5/11/12 Employee Health personnel was providing immunization support for staff members at Clinic. @ 0940 22YO female phlebotomist received Tdap injection in left deltoid and PPD in left forearm. Employee stated no known allergies and had no contraindications to receiving the vaccine. @ 0950 employee returned to conference room stating that she felt "dizzy and light headed" and was having "trouble breathing". Skin was flushed with patches of raised erythema over neck, chest and upper arms. Escorted employee to outpatient phlebotomy on first floor to supine position in chair. Placed on 6L o2 via NC. Lung fields clear despite c/o difficulty breathing/swallowing. A&Ox3 but had difficulty formulating sentences in her attempts to answer medical questions. Able to follow commands and MAEs w/o difficulty. Directed phlebotomist to contact RN on call who arrived shortly thereafter with another RN from bone and joint. On call RN left to find BP cuff because none were in blood draw area. RN returned with BP cuff and crash cart. @ 1005 directed lab personnel to call 911. Vitals signs BP 118/84, radial pulse 104 w RR 18-20 unlabored and O2 sat 98- 100% on 6l O2 per NC. Paramedics arrived @ 1015 to take her to ER. Prior to transport to ED vitals 142/88, pulse 96 RR 18-20 unlabored. Employee received Benadryl along w 1L NS IV in ED. Symptoms resolved @ 1330 followed by discharged. Came to EHC for follow up care the morning of 5/14/12. Asymptomatic at time of evaluation. A&Ox4, speech was fluid and clear, followed commands, had some recall of events taking place on 5/11/12. Was aware of her inability to speak and reported paramedic personnel voices distorted. Reported feeling "more tired than usual" over weekend, sleeping 14 hours 5/11/12 and 5/12/12 as well as citing brief episodes of confusion. Instructed to her to notify her PCP of reaction and to seek medical attention immediately in symptoms returned.
I started feeling like I was having a head cold with bad sinus pressure, I was tired and had a sore throat. I had bought flowers and noticed I could not smell them, then baked cookies and couldn't smell that. It was not until I was boiling vinegar to clean that it clicked and I took two home tests and they were positive for Covid. I called my Dr. and they sent over PAXLOVID. I had this bad cough, I couldn't talk and my voice was going in and out. I was exhausted and my throat continued to hurt. I will test today to see if I am still testing positive but am feeling better than I had been.
continuous pain in arm 2 days after shot, cant move swollen red mark on arm wont go away cant sleep
Flu like symptoms; Swollen lymph node under left armpit; Along with a severe headache; After the second dose she experienced chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), LYMPHADENOPATHY (Swollen lymph node under left armpit), HEADACHE (Along with a severe headache) and CHILLS (After the second dose she experienced chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), LYMPHADENOPATHY (Swollen lymph node under left armpit), HEADACHE (Along with a severe headache) and CHILLS (After the second dose she experienced chills). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Along with a severe headache) and CHILLS (After the second dose she experienced chills) had resolved and LYMPHADENOPATHY (Swollen lymph node under left armpit) had not resolved.            No concomitant medications were reported. No treatment details were reported.
Chills began approx. 7 PM night of vaccination, followed by fever two hours later. Mild headache followed and continued into the following day, along with some lethargy.
Patient presented to the pharmacy 2 days after receiving PNEUMOVAX 23 with 3 half dollar size red rash on the upper arm around the injection. The area was red and a little raised. The patient started on BENADRYL and by the next day was much better.
Patient received MENVEO, GARDASIL, and BOOSTRIX on 1/16/13. On 1/17/13, he developed increased redness, pain, and swelling of the right arm, where immunizations given. He was seen at our office 1/18/13 by NP and she suggested symptomatic care of cool compresses, IBU and TYLENOL. Recheck if symptoms persist or increase in severity.
At 11 hours post dose: Oral temp 99.6F. Took Ibuprophen, and temperature returned to normal. At 24 hours post dose: Temperature normal, but sinus drainage and coughing began (similar to seasonal allergies). No medication taken. At 72 hours post dose: Urticaria appeared over one hour on the inside of both arms and legs and scalp.  My scalp itched moderately. I took Benedryl 25mg po q6h x 2, then Loratidine 10mg po before bed (No further medication was taken). Coughing and sinus drainage resolved after beginning the antihistamines. The urticaria had resolved on my arms and legs by 96 hours post dose. The scalp itching was resolved in another 24 hours.
Had injection. Next day cut the grass. On Saturday woke up with rapid heart rate and shortness of breathe. Went to ER. New onset atrial fibrillation. Placed on medications for same.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 20-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 72 and 40. The lowest recorded temperature was 28. The highest recorded temperature was 47. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt is not 18 years old and  received moderna vaccine by mistake.  He has had no adverse event from vaccine.
Information has been received on May 15, 2001, from a consumer concerning her child (age and gender unspecified). Medical history was not provided. The patient experienced developmental delay (developmental delay NOS) due to mercury toxicity (metal poisoning) following immunization with Acel-Imune and Hib-Titer vaccines. The mercury toxicity was considered medically important. No further information was available at the time of this report.
The patient received MMRV instead of Varicella and MMR separately.  No adverse affect noted
CDC Reports: 1 yo child recvd DTP/OPV 6Feb90.  8Feb90 developed fever 106 (R), taken to ER treated /w Tylenol, Temperature went to 102, duration of fever 2 days.
A week after the injection I started getting headaches, and now the injection site is red, swollen, itchy, and warm to the touch.
Modern a COVID-19 Vaccine EUA:  Approximately 3 hours after vaccine administered my right arm started to become sore minimally. As evening came arm very sore and hurt to move. Evening of first day of shot some fatigue. NO FEVER.  Day 2:  afternoon noticed rash on parts of torso and neck. No itching. Approximately 4:00 took one Benadryl for rash.  Day 3 Monday January 18 rash mostly gone with small area on neck and a small patch on left side of face. Took one Benadryl at bedtime.  Day 4: Tuesday January 19 rash completely gone.  24 hours after shot administered arm only slight soreness but mostly gone. Noticed some heart palpitations off and on which are part of my medical makeup
I tested positive for COVID-19 on 12/3/22. I had a runny nose, and a scratchy throat at first. Then I developed flu like symptoms of congestion, headache, and fatigue. I contacted my doctor and was prescribed 5 days' worth of PAXLOVID. I am feeling much better now.
Shortness of breath as fast as 1 day after administration. Is having some hot flashes. Symptoms exist - two weeks after injection.
Pain on her arm that later radiated to her R shoulder causing severe pain limited ROM and swelling on the supraclavicular area. Pt has history of diverticulitis and Polymyalgia Rheumatica
This spontaneous report as received from a pharmacist refers to a 77 year old female patient. On 16-APR-2013 the patient was vaccinated with ZOSTAVAX (lot# unspecified), subcutaneous. On 01-MAY-2013, the patient developed shingles approximately two weeks after receipt of ZOSTAVAX. VZVID packed was sent. The outcome of shingles was reported as not recovered. Additional information has been requested.
Discrepency on dilution and dosage amount noted on 1/23/2023 for COVID-19 monovalent, Dose #1. Provider notified, manufacturer contacted for advisement, patient parent contacted.  Child exhibits no adverse reactions and remains asymptomatic. Per manufacturer patient will need to repeat Dose #1 for COVID-19 monovalent vaccination. Parent aware and verbalizes understanding.
On the first day: mild fever, body aches, extreme fatigue, mild nausea, redness at the injection site. On the second day: all of the symptoms of the first day. In addition, a raspberry colored blotch extending downward from the shoulder down to approximately half of the bicep and hot to the touch. On the third day: normal temperature, the red bloch extended downward and under  the arm reaching close to the elbow with swelling of the affected area. On the fourth day the swelling increased.
Syncopal episode x 2 . Vitals remained stable throughout . Felt dizzy for approx 30 minutes
That day I had the vaccine where I previously had shingles (3 weeks earlier) got really red and hot and other than that I had no effect. I didn't think much about it because I had no fever. The next morning I woke up itching and didn't know you could break out again with the shingles. Once the rash started appearing and looked just like shingles I called for a doctors appointment. They put me back on Valtrex and I took that round for 7 days and I was still broken out and they called for 3 more days and then it cleared up.
This case was reported by a physician via other manufacturer and described the occurrence of splenomegaly in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included ruxolitinib phosphate (Jakafi) for myelofibrosis. On an unknown date, the patient received SHINGRIX at an unknown dose and Jakafi (oral) 5 mg twice daily (10 mg daily). On an unknown date, unknown after receiving SHINGRIX, the patient experienced splenomegaly. The action taken with Jakafi was unknown. On an unknown date, the outcome of the splenomegaly was unknown. It was unknown if the reporter considered the splenomegaly to be related to SHINGRIX. Additional case details were provided as follows: The age at vaccination were not provided; however captured as Adult as per vaccine indication. The patients' medical history and concomitant details were not available. The patient was vaccinated with SHINGRIX and experienced (Speen grew) Splenomegaly. It was reported that the patient initiated the use of oral Jakafi (ruxolitinib) 5 mg tablet twice a day from the unknown date for Myelofibrosis for 1 month (batch number and expiration details were not provided). It was unknown if the reporter considered the splenomegaly to be related to Jakafi. No other information was provided.
Only the diluent part of PENTACEL was given to the patient so per employee at clinic, she states the patient only received IPV and Dtap and will need a separate HiB vaccine. Proper forms and documentation took place in our charting system.
Extreme soreness at vaccination sight, weakness, nausea, chills, eventually high fever (103) with body and joint aches.  By the 3rd day the site of the vaccination have multiple red patches and there was continued nausea and soreness in the arm.
Patient was initially presented on 1/5/2022 with  a chief complaint of bilateral thigh and lower back pain.  Patient tested positive for covid however asymptomatic with infection.  Patient reported that she was previously diagnosed to have myositis of unspecified etiology and was treated with steroid and Dilaudid. Patient was subsequently admitted for elevated CK due to rhabdomyolysis. Total CK level started to trend down and subsequently normalized.  Patient was also treated with IV fluid .  Patient was prescribed tapering dose of prednisone, Lyrica, Zanaflex and Norco for pain control.  Patient remained stable and was discharged at stable condition.
The wrong shot was given on a mistake on 9/18/23 at 11;44am and the parent was call in noticed.
Developed very itchy rash and malaise 2 weeks after booster vaccine. Since biopsies and diagnosed as Grover Disease.
Fever?101 Chills Body aches Headache Nausea Extreme fatigue
Left side of face swelling in cheeks and gums. I wasn?t experiencing this pain or issue before shot.
Sudden intense itching at the injection site presented exactly one week after injection. Within 12 hours, a full rash developed near the injection site about 6'' x 4'' with welts that turned into a solid red area. Was gone within 48 hours.
I tested positive for Covid-19 on March 07, 2023 with home test provided by govt. I had a Telemedicine Appointment with staff at the Family Medicatl Center while in city and took Paxlovid.. Symptoms were primarily upper respiratory and I was treated for a sinus infection by Staff  with Prednisone on April 04, 2023.
(Th 10pm) 1st day - 102 degree fever for 3 days, body aches, super sore arm, major headache - went down to 101 with Tylenol  (Fr) 2nd day - Super light headed, could barely walk or move without almost passing out, fever, worse body aches and arm - took tylenol to bring fever down to 100 degrees, all the same symptoms as day 1 but more intense, eyes also dry and hurt. Red bumpy itchy rash started on the right upper arm (not injection arm or area), near armpit, but not in armpit. Started to extend down towards crease in elbow.  Applied a steroid cream and took 2 benadryl to the rash. - slightly lessened the extent and color of the rash. (Sa) 3rd day - same type of rash on the right arm, now was on the left arm. Applied steroid cream and took a zyrtec. Took 2 benadryl at night. Still have headache, sore arm and eyes hurt.  (Mo) 4th day - rash lessened, but was still visible- continued with steroid cream and benadryl . Fever went down. (Tu) 5th day - Took zyrtec in AM.   Still felt weak and tired. Rash on arms started to disappear, red bumpy rash on the stomach appeared. Had a headache, took 1 Tylenol.  Took benadryl - rash went down after a few hours.  (We) Rash is gone, continued to feel tired and out-of-it. Injection arm still sore (left arm).
This is a spontaneous report from a contactable other health care professional (patient). A 70-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, Lot number: EN6198) administered on left arm on 23Feb2021 13:30 via unspecified route of administration as a 1st dose, single dose for Covid-19 immunisation at a pharmacy or drug store. Medical history included Pre diabetic. Concomitant medication included Lisinopril (MANUFACTURER UNKNOWN), Fluoxetine (MANUFACTURER UNKNOWN), Levothyroxine (MANUFACTURER UNKNOWN), Lovastatin (MANUFACTURER UNKNOWN). Patient had no allergies of food, medicines and other medicinal products. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. On 23Feb2021 18:30, the patient experienced left upper arm soreness. About 5 hours after injection, her upper arm got very sore. She could not put pressure on it trying to lay down on left side as very sore. Felt as though someone slugged her as hard as they could. Was pretty much gone by am. No treatment was received for the adverse event. The clinical outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Seizures:  Body involuntarily shook, eyes rolled back into his head intermittently for several minutes on and off for about 6 hours.  102 degree fever, inconsolable crying. toxic smelling diapers, refusal to eat, sleeping for 18 hours straight.