chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Onset approximately 4am Sunday Feb 14 I experienced extreme fatigue, nausea with dry heaves.  Stayed in bed ll day, only rising to urinate or for dry heaves.  Did not eat or drink  anything until 5am Feb. 15 when I had 2 cups of tea.  Nausea gone, able to eat.  However to date Feb. 17 I am extremely weak,  shaky. , afraid to shower for fear of falling.
Stomach discomfort, diarrhea, slight elevated temperature, irritable, light rash around mouth and torso, behind legs and neck.
The patient was brought to the immunization room for her 4 month vaccinations. She had been evaluated by the physician for a well child check prior. The child was awake, alert, and active. She was given 3 injections and one vaccine orally. She cried appropriately and withdrew from the injection sites. She quieted once her mother picked her up and cried again when her mother laid her back on the table to dress her. Mother gathered her belongings and left to check out. Per the mother's report, she walked down our sidewalk (about one minute) and was visiting with the child's grandmother who works nearby. She was standing holding the child vertically facing outward so she could play with grandma. The child was cooing and playing and then suddenly her head slumped to the side and she became completely limp. The mother was not certain what had happened and the grandma said she thought the child had passed out. They attempted to awaken the infant without success and after a few minutes, proceeded back to the clinic for re-eval. Per mom's report, the child was completely unresponsive and limp for greater than 5 minutes (but less than 10 minutes because she had not been gone from the immunization room for 10 minutes when they returned). The child was brought into the immunization room and placed supine on immunization table. She slowly opened her eyes and looked around with her eyes but not moving around otherwise (had muscle tone but not a lot of moving). She was still quite groggy. She was breathing even and non-labored, heart rate was WNL, no color change, and no shaking noted through out my assessment (nor was any reported by the mother during the event prior to my assessment). After observing for approximately one minute, the patient was returned to the exam room for the physician to re-evaluate the patient. While walking with the child being held vertically, she was holding her head up spontaneously and looking around.  She continued to become more alert and active, but still not as active as she had been when she initially arrived for the immunizations. Dr. re-examined the patient and found her breathing even and non-labored at regular rate and heart rate at normal rate. Rectal temp was taken as 98.7 degrees F. Dr. felt the child probably had a vasovagal syncopal episode and would continue to recover.  The infant was observed for a total of 20 minutes after returning to the clinic.  She was then discharged with her mother with instructions to call us or proceed to the nearest emergency room if the event occurred again, she had any shaking episodes, had high fever that would not respond to anti-pyretics, any prolonged crying and fussy episodes, or not eating and drinking normally. Mother agreed and verbalized understanding. I called the mother this morning, 24 hours after episode and she reports the child was acting normally. She reports she had a fever yesterday afternoon of 99.0-100.5F (taken rectally) and took a long nap and is now acting completely normally.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A 58-year-old male patient received bnt162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: ep6955) and on 12Apr2021 as dose 2, single (Lot number: ep6955) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "CNS Lyme Disease" (unspecified if ongoing). The patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received PAXLOVID as COVID 19 Treatment on 22Sep2023.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2 cannot be completely excluded.
The following day after the second shot. I had started to get serious pain in the armpit/swollen lymph node. I have had swollen lymph nodes in the past for certain infections so theres a chance I have a predisposition to getting them, but haven't had an issue in many years. However, I reached out to a friend that works for a company and she said to report this. The deep lymph node in my left armpit is many times larger than the left and I cannot let my arm rest at its side due to the size and pain.
he has had a "toe problem for a while now"; This is a spontaneous report from a Pfizer-sponsored program from contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via unspecified route of administration, on 05Feb2021 (reported as last Friday) as a single dose for COVID-19 Immunisation. Patient's medical history and concomitant medications were not reported. Patient reported that he had a "toe problem for a while now'' in Feb2021 and planned to see his doctor about it who may or may not prescribe antibiotics. He inquired if it is ok if he takes an antibiotic if one is prescribed. The patient stated about toe problem that ''this is not due to the vaccine''. Outcome of the event was reported as unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on information given in the narrative, the reporter has denied the causality by stating that toe problem is not due to the vaccine. Hence the event is considered not related to the suspect vaccine.
Patient positive for COVID after being fully vaccinated.  Positive test 6/8/2021,  Was vaccinated 3/27/21 and 4/17/21.  Asymptomatic, tested after exposure at work.
Developed strong tinnitus in left ear.  This ear has very slight high pitched hearing degradation prior.  After first dose slight intermittent tinnitus developed.  Almost immediately after second dose persisting tinnitus developed in left ear.  Right ear appears unaffected.
This spontaneous report as received from an other health professional refers to a patient of unknown age and gender, with no concurrent conditions and medical history reported. On 17-JUL-2017, the patient was vaccinated with improperly stored (18 hours in temperature -12 Celsius degrees) PROQUAD lot # M041083, therapy type RHA, expiration date 04-APR-2018 (route of administration was not reported), for prophylaxis. Other suspect therapy included sterile diluent lot # K019027, expiration date 07-AUG-2017 (dose, frequency and route of administration were not reported). No adverse effects were reported. This is one of four reports from the smae reporter. Sender's Comments: US-009507513-1709USA000305: US-009507513-1709USA000306: US-009507513-1708USA002682.
Case was hospitalized for Covid less than 2 months after completing Covid vaccination.  Hospitalized at: Hospital. Discharging physician: MD.   Pneumonia due to COVID-19 virus Assessment & Plan Symptoms started approximately 9/18. Most prominent symptoms include fevers, poor PO intake, cough. Tested positive for covid on 9/22. He was vaccinated w/ J&J Obesity and unchecked diabetes increases risk for severe disease. CRP 2.96 on admission, down to 0.87 9/29. - Dexamethasone, finished 10-day course this morning - Remdesivir, finished 5 day course on 9/28 - Baricitinib, completed 5 days of therapy prior to discharge - IS, self-proning, and ambulation as able - Oxygenation greatly improved last couple days, no longer ICU status. Back to nasal canula. Home oxygen arranged - Supportive care for fevers and cough oral intake has improved  Acute respiratory failure with hypoxia   Assessment & Plan Secondary to covid-19 infection. 88% on room air on admission, requiring 3L initially but then needed 60L high flow 9/28 prompting transfer to ICU. CT pulm angio neg for PE on 9/27. Viral pneumonia displayed. Now liberated from the high flow setup and on 2L, stable overnight.  -Home oxygen arranged, he will use IS at home as well.
Cannot lift her arms above her shoulders/can't do anything; Pain in her neck; Pain in her groin; Can't walk because the pain in her legs is horrible/pain went down to the right calf/pain went to the hip/pain in arms; Excruciating pain; Pain in shoulders; >35 days of vaccine admistration 1st dose 02-Mar-2021,2nd dose 14-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Cannot lift her arms above her shoulders/can't do anything), NECK PAIN (Pain in her neck), GROIN PAIN (Pain in her groin), PAIN IN EXTREMITY (Can't walk because the pain in her legs is horrible/pain went down to the right calf/pain went to the hip/pain in arms) and PAIN (Excruciating pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days of vaccine admistration 1st dose 02-Mar-2021,2nd dose 14-May-2021). In July 2021, the patient experienced HYPOKINESIA (Cannot lift her arms above her shoulders/can't do anything), NECK PAIN (Pain in her neck), GROIN PAIN (Pain in her groin), PAIN IN EXTREMITY (Can't walk because the pain in her legs is horrible/pain went down to the right calf/pain went to the hip/pain in arms), PAIN (Excruciating pain) and ARTHRALGIA (Pain in shoulders). The patient was treated with OXYCODONE for Pain, at an unspecified dose and frequency and CANNABIDIOL (CBD OIL) for Pain, at an unspecified dose and frequency. On 14-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days of vaccine admistration 1st dose 02-Mar-2021,2nd dose 14-May-2021) had resolved. At the time of the report, HYPOKINESIA (Cannot lift her arms above her shoulders/can't do anything), NECK PAIN (Pain in her neck), GROIN PAIN (Pain in her groin), PAIN (Excruciating pain) and ARTHRALGIA (Pain in shoulders) had not resolved and PAIN IN EXTREMITY (Can't walk because the pain in her legs is horrible/pain went down to the right calf/pain went to the hip/pain in arms) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was reported that patient went to a cardiovascular doctor and had 3 MRIs done and they had not found anything. CBD oil does not help the pain,the only time it gets better is at 5 pm and if she keeps walking, and that only helps her legs.
-0 to 1 day after vaccine: moderate left deltoid soreness, resolved completely -3 days after vaccine: new left axillary soreness and mild axillary lymphadenopathy  -7 days after vaccine: worsening left axillary pain and lymphadenopathy with several axillary lymph nodes 1 cm in diameter. Lymphadenopathy now extending to left supraclavicular nodes and left anterior cervical chains. No other lymphadenopathy noted (I.e not bilateral). Erythema and new soreness appears over left deltoid in a 4cm patch. Seen by urgent care. Advised to report symptoms to CDC via V-safe app
Patient was administered the incorrect vaccine/dose.  Patient was supposed to receive a Pfizer booster for the 5y to 11y age group and was given .3ml of the Pfizer Bivalent booster. Patient did not report adverse reactions to staff after receiving the vaccine.
Onset was the next morning around 7:00 AM after the vaccination. 2 red very warm areas about the size of a quarter an inch below the injection site. no itching, just really warm. and it was pink. The same day I  called my doctor, he told me over the phone to take Benadryl, 1 capsule early in the day, and 1 capsule later in the evening.  and the day after I took 1 capsule.  and it slowly faded away
2/16/23 I had a sore throat, fairly minor. The next day, I began coughing, had a sore throat, a low-grade fever, head and chest congestion. That evening, I took an at home COVID test that was positive. The next day I had a PCR test done at the pharmacy which was positive. Also had a Flu A & B, negative. On 2/18/23, I had flu like symptoms and head cold symptoms, aches, and had a fever of about 102 that lasted about 12 hours then improved. I also had diarrhea. The cycle continued for about a week or so. I lost my sense of smell. On 2/24/23 I took an at home COVID test which was still positive. On 3/4/23 I took another at home COVID test which was negative. I went back to the doctor because I continued to have chest congestion, coughing, tinnitus, lack of smell, but slowly coming back and congested eustachian tubes. I went to the doctor on 3/14/23 and I was given prednisone prescription and an albuterol inhaler. I have not recovered.
Excessive itching and tingling on right arm and it took months to heal any cut or bruise
received 2 FLUZONE QIV np injections 8 days apart, with no reported adverse event; Initial information received  on 15-Feb-2023 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 6-month-old male patient who received 2 INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] injections 8 days apart, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 01-Nov-2022, the patient received a 1st dose of suspect INFLUENZA QUADRIVAL A-B VACCINE at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for immunization. On 09-Nov-2022 he also received a Second dose of the same vaccine at a dose of 0.5 ml once (lot UT7723LA, expiry date: 30-Jun-2023) via intramuscular route in unknown administration site for immunisation.  On 09-Nov-2022 the patient received 2 fluzone qiv np injections 8 days apart, with no reported adverse event (inappropriate schedule of product administration) 8 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE first dose and same day latency following the second dose.  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Screaming, inconsolable, fever 102.6 w/in 6 hours lasting >120, Rx Motrin, Tylenol.
a place on my arm got red; it's fevered; it started itching; I scratched it; Tiny bumps above injection site, bumps went away but not sure when.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (a place on my arm got red), VACCINATION SITE WARMTH (it's fevered), VACCINATION SITE PRURITUS (it started itching), SCRATCH (I scratched it) and VACCINATION COMPLICATION (Tiny bumps above injection site, bumps went away but not sure when.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus (for the past three or four years) and Allergy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ROSUVASTATIN CALCIUM (CRESTOR), FISH OIL and METFORMIN for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (a place on my arm got red), VACCINATION SITE WARMTH (it's fevered), VACCINATION SITE PRURITUS (it started itching), SCRATCH (I scratched it) and VACCINATION COMPLICATION (Tiny bumps above injection site, bumps went away but not sure when.). On 08-Mar-2021, VACCINATION SITE PRURITUS (it started itching) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (a place on my arm got red), VACCINATION SITE WARMTH (it's fevered) and SCRATCH (I scratched it) outcome was unknown and VACCINATION COMPLICATION (Tiny bumps above injection site, bumps went away but not sure when.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also included unspecified allergy medication, sleep medication and nerve medication.  Treatment information was not provided.
After vaccination on 1.8.21 felt fatigue, metallic taste, and intermittent tingling. on 1.15.21 at approximately 8 am developed occipital headache (4/10 pain) inability to move right upper or lower extremities and slurred speech. No evidence of  intracranial hemorrhage on CT. Patient administered Alteplase and transferred to higher level of care
10 second after the vaccine my are was tight and swollen. the third day after the vaccine I noticed that below the injection site I was bruised. I noticed discoloration (light blue , light back )  My arm cleared within 8 days  I had a metal taste in my mouth  I also had a headache
lt thigh tender along quadriceps; pt apprehensive about passive ROM of hip prom lt hip; myalgic secondary to DTP advil susp, rest cal if necessary;
Severe rash began to appear 8 days after the moderna covid-19 vaccine. Large areas of rashes occur on the upper part of both legs, upper body, neck and face. Waited for another day to see if the side effects will disappear on the 9th days. But the rashes become even worse. Seeing the Dr. on April 30th at 11:10am. She prescribed Prednisone 20mg  for 2 pills a day for 5 days. She also asked me to take Clariton 10mg 1 pill a day for 7 days. This is my second day after seeing the doctor. The swelling becomes less severe, but the rashes continue to be big.
Mom noted redness with swelling at site of immunization on right arm. No fever, tenderness or refused to move arm.
This spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 13-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J007955; expiration date 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
pt recvd vax; mom stated pt cried continuously all noc into the am; pt adm to hosp for observation; T 100.6;
her arm as there was significant redness; swelling at injection site; was given "below the deltoid not in muscle"; This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2020, the patient received the 1st dose of Shingrix. On 21st September 2020, unknown after receiving Shingrix, the patient experienced wrong route of administration. On an unknown date, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the wrong route of administration was unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional information was provided as follows: The patient experienced significant redness and swelling at the injection site after the 1st dose of Shingrix. The reporter mentioned that, the dose was given below the deltoid and not in the muscle, which led to incorrect route of product administration. The reporter wanted to know if the dose was still valid. No other information was provided. The reporter consented to follow up.
1 week after covid shot on 1/18/21,  I missed a day of work for stiff neck followed by a headache. Over the next 3 weeks, my headache increased in nature, and accompanied with stiff neck, stiff hips and I could only lay on my back to sleep. The headache was mainly on my right side behind my eye.  I tried a high dose of naproxen, as well as massage, chiropractic and got no relief.  Finally on  February 2nd,  I went to the urgent care associated with my primary care provider because my primary care provider was not available.
Minor was accidentally given a 2nd dose of vaccines first dose was given on 8/9/23.
I was notified of vaccines administered outside age range. Report showed 8yr old given 12yr+covid vaccine documented on 1/20/2022. It also show historical covid vaccine on 11/21/21 also.
Regarding The VSIR for  the following COVID Vaccine Moderna. Please see the following determination; Doses Administered from 4.6.2021 to 5.21.2021:Based on the information you have provided and the lack of temperature data, we are not able to conduct an analysis or guarantee the doses administered between 4/6/2021 and 5/21/2021 provided the necessary protection against a COVID-19 infection. Please continue with the original plan of action on revaccination and completing a VAERS Reports on the all clients you have identified.
Had regular labs for bloodwork every month to monitor since stem cell transplant. Had CBC March 17. Platelets had been going up to 125,00. Then dropped to 118,000 on Feb. 17 which is "normal". After vaccine, dropped from 118,000 to 95,000! Drooped to 79.000 on March 29. Dropped to 66,000, 55,000 and 35,000 on consecutive bloodwork that became more frequent!  Had t-cell chimerism lab to show still 100 percent donor. Having bone marrow biopsy tomorrow, April 26, 2021.
Approximately 3 minutes after the shot was given we were walking out of the facility, in the parking lot, and patient said she felt light headed and she began to sway. I put my arms around her so she would not fall and asked her what she was feeling. Her body started making jerking movements and her head went backwards and her eyes went wide open but she was not blinking and didn't seem to be aware and she did not answer my questions. She then went limp. I screamed for help and they brought a wheelchair out to take her inside. They said to not worry that she had just fainted. They took her blood pressure and gave her some juice. Asked if she had eaten breakfast. Told them that she had. They observed her for 10-15 minutes and then said we were fine to go home. No symptoms since then. She did not flinch or wince when they gave her the shot/did not express any pain. However, she does not remember leaving the office and has a vague, dreamlike memory of the reaction. Not sure if this was fainting or a seizure.
STARTED 10.4.23 AND STILL PRESENT. ON BOTH ARMS, CIRCULAR REDNESS AT INJECTION SITE. REDNESS LOOKS AS BIG AS TANGERINE ON BOTH DELTOIDS. HAS SORENESS AND MINIMAL ITCHING