chrisvoncsefalvay/vaers-outcomes huggingface dataset:
While at school two hours after her shot, her teacher noticed her leaning towards her left side, she couldn't stand up straight at the playground, and kept falling down, then standing back up and then would fall again. Her teacher ran to her and that is when patient stated her legs were numb and she couldn't walk. However, the way she was saying it wasn't making sense. Just that her leg wasn't working. They brought her in, she had patient lean against the wall so she could get the rest of her class and when she got back in patient was on the floor again, her left side kept jilting, like shaking back and forth. Her entire left side only and she was spacing out. They called an ambulance and when I got there, the ambulance was there and her left side was still jilting. We took it to the hospital and while in the ambulance she said she couldn't lay down as it hurt her back badly and her legs so they had to sit her up and the pain got better. When we got to hospital, they stated she needed an x-ray on her leg and that she may have had a grand mal seizure. However after the x-ray was clear they just sent us home saying she had three random seizures and to schedule an app with a neurologist and her primary despite me stating it was abnormal for her to have seizures and no reason besides her just having her flu shot that morning. They sent us home anyways, we got home and noticed the leaning again she was doing it with her right side again and was spacey. Though she was moving and what not she was not making sense and was again just not talking and it was like she was looking beyond. Again we had her lay down and she continued to do that and then the tingling in her legs and back came back and she became overwhelmed with pain and I sat next her to and she stated I was sitting on her foot and I wasn't I was sitting next to her tummy and not on her foot. Then I asked her what hurt and noticed her right shoulder jolting again like her previous seizures and she stuttered IDK loudly due to pain, frustration and I'm sure the seizure. She ended up sleeping a lot like 20 hrs the next day it continued. I took her to the ER where they admitted her, did an MRI and EEG but didn't see anything and we saw Dr., a children's neurologist who stated her iron levels were on the low side and that he felt the drug (the shot) could have done it but they weren't sure what caused it, despite me providing a video of her behavior after we were sent home the first time from the ER. We have diazepam on hand for when the seizures last longer than 5mins. Her sleep patterns are off, her mood swings are awful now, and she gets frustrated and tired WAY easier than ever before and she's been having issues communicating with us even more. We won't know more until she gets older on how extensive the damage is.
Patient was administered his first vaccine on 9-6-13. Within 30 minutes he was sleeping and proceeded to sleep for 3 hours. Mother woke him for dinner. (approx 6:30 pm). Marked decreased appetite was observed. He fell asleep again approx 7:00 pm and slept for 15 hours. He had previously been a frequent night waker, nursing 2-3 times per night. The following day the vaccine injection he developed a low grade fever. Additionally, beginning this day, he would scream and scream and scream. He would double over in pain and continued to scream. This was sometimes accompanied by explosive diarrhea. When he was not screaming, mother and father attempted to engage him in play. He would stare into space. He would not smile, he would not laugh, in contrary to his usually bright and bubbly personality. He was again very sleepy this day following the vaccine and showed marked disinterest in solid food. Continued to breastfeed. At night and for the next several days and nights, he would moan and whimper in his sleep. - all night long. His sleep was restless and accompanied by much tossing and turning. Close contact was kept with the Pediatrician throughout the weekend who agreed increasing probiotics may be helpful. He was also brought to a Naturopathic Physician who prescribed 1/4 tsp probiotic 1 x daily, 5 drops Thuja 1 x daily and 5 drops of Anticromian Crudum 3 x daily. Follow up visit was done with Pediatrician on Sept 10th. The above symptoms lasted nearly a week and a half with symptoms peaking between 1-4 days following the injection and slowly beginning to taper off. He appears to be recovered as of the writing of this form.
About 12 hours, after vaccination started to feel nauseous with a bad belly ache and vomited about every half an hour for 5 Hours and very bad vomited. I then called my on-call Doctor and she stated to go to the ER but to know that it is a side effect of the vaccine and pain was intense on my lower abdomen and then I went to ER right away at noon; Hospital and they said my appendix was very large and I would need to have emergency surgery within 2 hours. Appendix was contained with gain green.
Patient developed lightheaded sensation and wheezing 10 minutes after vaccine.  She was sent to the emergency room for close observation, given a single dose of steroids and diphenhydramine, and discharged home without further complication.
not sure if activated the gout in that foot; Woke up this morning and right foot was killing him; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (not sure if activated the gout in that foot) and PAIN IN EXTREMITY (Woke up this morning and right foot was killing him) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified. Concomitant products included APIXABAN (ELIQUIS) for Heart disease, unspecified.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced GOUT (not sure if activated the gout in that foot) and PAIN IN EXTREMITY (Woke up this morning and right foot was killing him). At the time of the report, GOUT (not sure if activated the gout in that foot) and PAIN IN EXTREMITY (Woke up this morning and right foot was killing him) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-034389 (Patient Link).
Extreme Fatigue, Fever, Chills beginning 24 hours after 2nd dose, & lasting for 12-16 hours. Skin rash on arms, back, chest, stomach that developed 3 days after 2nd dose
Pt got Moderna COVIDvaccine on 6/4/21 in the evening  and said she had some headache on 6/5/21 we told her to take Tylenol and let us know if it helped or got worse. She called back today 6/7/21  stating that the Tylenol worked for the headache. However, her husband mentioned to her that over the previous 24 hours, she had episodes of confusion where she didn't understand what he was saying. We gave her VAERS phone number so she could report it and counselled her to go to the ER to get proper care and to reach out to us about the outcome of the visit
Dec. 10th - first migraine which took him down for a day, since then he's had headaches/migraines every day since, accompanied by some dizziness. Saturday (1-29-22) he took a really bad turn, while watching TV , his eyes started repeatedly drifting to my right then snapping back and he lost all equilibrium, felt like he was falling. Next morning - two more of these episodes, one when eyes were opened, one when closed, this was accompanied by sweating and nausea. The rest of the day (Sunday 1-30-22)  migraine was intense and my equilibrium was shot.
Day after - woke up with numbness in toes and fingers. Proceeded to numbness and shooting nerve pains in feet, hands. 4 days later broke out in shingles rash. 10 days later in so much pain went to ER. Then said it was an adverse neurological event from first  moderna COVID vaccine.
During vaccine clinic nurse was attempting to administer vaccine. Syringe was not securely tightened and medicine spilled down patients arm during administration. Nurse estimates that only 25% of medication went into patients muscle. This occurred at the pop up vaccine clinic patient had to be poked twice, needle wasn't screwed on syringe well so very minimal was given first round, was approved by Dr. to do second attempt
IMMUNIZATIONS ADMINISTERED ON 7/17/06. ON 7/19/06 PT WAS SEEN WITH A SMALL NODULE APPROX. 1/2 CM IN MID LEFT THIGH. NOT OBVIOUSLY TENDER. GAIT APPEARED NORMAL.
THE LEFT DELTOID AREA OF THE ARM TURNED RED AND BECAME TENDER. IT HAS FEVER IN THE AREA
Lump under left arm pit. Lump is about the size of a quarter. Lump is not sore when touch. Lump appears to be shrinking. Noticed the lump 30 Apr 2021. Contacted my Primary Care Physician on 3 May 2021.. Physician stated if the lump gets larger or is sore to touch to go to an Urgent Care or Hospital Emergency
MORE BLOOD CLOT; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: blood clot. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 01 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient reported he suffered from blood clots and believed he suffered from more blood clots (aggravated condition) after receiving the Johnson and Johnson Covid shot on unspecified date. The action taken with covid-19 vaccine was not applicable. The outcome of more blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211023460- covid-19 vaccine -more blood clot. This event(s) is considered not related. The event(s) has an unknown/unclear 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: MEDICAL HISTORY
Headache, mild photophobia T=99.8 F, neurologically intact; day #6 of vaccine. Tx with Naproxen; quarters x 24 hrs-improved.
Information has been received from a registered nurse concerning a 15 month old male with no pertinent medical history or allergies who on 08-MAY-2008 was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (LOT# 659724/1660U). Secondary suspect vaccination included a dose of MMRII. The nurse reported that on 12-MAY-2008 the patient was experiencing chickenpox. The patient had twenty "red watery" blisters on his back and three blisters on his chest. No diagnostic studies were performed. At the time of the report, the patient had not recovered, and had no blisters on the arms or legs. Additional information has been requested.
Outbreak of Herpes; This is a spontaneous report from a non-contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced outbreak of herpes. The patient wanted to know if she can take valacyclovir for an outbreak of Herpes after being vaccinated with the Pfizer Covid vaccine. The outcome of the event was unknown. There was no product quality complaint (PQC) present.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from an RN concerning a female pt who in 11/99 was vaccinated with a 2nd of Hep-B and subsequently, the pt experienced weakness at the injection site (left side). It was noted that the pt's symptom persists. Unspecified medical attention was sought. Additional information has been requested.
Vaccine on Jan 25, 2021    Minor seizure on Jan 31. 2021- 4:35pm talking, then staring, "blank stare", didn't recognize either daughter for about 10 minutes. Daughter did stroke tests, all normal. called 911, they saw no stroke symptoms, EKG normal. Within 15 minutes, he was coherent but lethargic. Could not remember 15 minutes prior. Did NOT take to ER. Saw cardiologist next day and then had head CT later that week.
Had the first dose of the Pfizer Vaccine; Came down with Covid; This is a spontaneous report from a Pfizer Sponsored Program. This is the first case out of two cases in which the reporter is reporting for herself. A non-contactable female patient (consumer) of an unspecified age reported for herself that she received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 02Aug2021 (Age at the time of vaccination was not provided) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated, she and her husband had the first dose of the Pfizer Vaccine on 02Aug2021 and they both came down with Covid on 10Aug2021. So, they were out of quarantine on the 22Aug2021 of this month and now they want to go get their second dose, but the doctor told them that they have to wait 90 days. The was transferring because of the adverse event. The patient mentioned "Correct, eight days after she got the Pfizer-BioNTech COVID-19 vaccine and she got Covid. She was no longer on the line now and no phone number was given. The patient hung up the call abruptly before warm transfer in Pfizer Drug Safety. Hence, product details (LOT#, Expiration date, NDC#, UPC#), Pharmacy details and other details could not be probed. Call back could not be done as no contact information was available. Hence, limited information was available over the call. The outcome of the event was reported as unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101105023 Same reporter/drug/event, different patient.
On Friday night, April 16,2021, after working all day for his job, Pt told his roomates that he wasn't feeling well, was throwing up, had the chills and was going to lay down. When the roomates didn't see him Monday morning, April 19, 2021, they went into his room and found him unresponsive. The medical examiner ruled death due to cancer which appears incorrect considering the evidence.
patient received menactra which was already expired/no AE; Initial information was received on 23-Jun-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient (unknown demographics) who was vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE which was already expired (batch number and expiry date not reported) via an unknown route as an unknown administration site on an unknown date for prophylactic vaccination (expired product administered)  Medical history, concomitant therapy,  medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to expired vaccine used.  At the time of report no adverse event was reported.  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 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.  There will be no information available on batch number for this case.
Itchy, blotchy rash 24 hours after shots, not accompanied by fever.
Had one dose of Pfizer and then got first dose of Moderna and then another dose of Moderna; Had one dose of Pfizer and then got first dose of Moderna and then another dose of Moderna; A spontaneous report was received from a healthcare professional concerning a patient who had one dose of Pfizer and then got first dose of Moderna and then another dose of Moderna.  The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, patient received one dose of Pfizer vaccine for prophylaxis of COVID-19 infection.  On unknown date, patient received their first of two planned doses of mRNA-1273 (Lot number: unknown), for prophylaxis of COVID-19 infection.  On unknown date, patient received their second of two planned doses of mRNA-1273(Lot/ batch number: unknown), for prophylaxis of COVID-19 infection.  Treatment for the events were not provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events, had one dose of Pfizer and then got first dose of Moderna and then another dose of Moderna, was considered resolved.; Reporter's Comments: This report refers to a case of Product administration error  of Extra dose administered  and Interchange of vaccine products for mRNA-1273, lot # unknown , with no associated AEs.
Pt in clinic 5/5/2010 and got a PREVNAR-13 shot. On Thursday, develop pain and swelling at injection site. Swelling worsened on Friday and was admitted to the hospital and tx w/ antibiotics for possible cellulitis? Per MD on exam, likely an arthus hypersensitivity reaction.
Information has been received from a health professional concerning an 8 year old white female, with history of allergic rhinitis, who on 10/30/1997 was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that the patient came into the office to have a rash checked that began on 12/09/2004. The patient had the rash for 4-5 days. The rash was diagnosed by the doctor as chickenpox described as a generalized rash in different stages. Subsequently, the patient recovered. There were no laboratory or diagnostic tests performed. Follow up information from a health professional indicated that the patient was seen in the office on 12/15/2004 by the physician for a skin rash that began on 12/10/2004. The skin rash was in itchy, generalized rash in different stages which was diagnosed by the physician as chickenpox. It was reported that the patient recovered in approximately 2 weeks, on 12/24/2004. Additional information is not expected.
Patient had severe swelling of the left arm, trunk, left breast, and it radiated out to her back. She reported difficulty breathing, difficulty swallowing and felt hot. She took benadryl and it got a little better so she did not go to ER.
pt called 7/30/99, right leg red & swollen, 3'' above inject down to the knee; advised oral benadryl & motrin, apply ice
Patient presented to the ED and was subsequently hospitalized for Severe sepsis with acute organ dysfunction within 6 weeks of receiving COVID vaccination.
Hives, recurrent after 1 dose dexamethasone and benadryl
Patient's mother reports the morning after receiving the Tdap vaccine, patient's arm began to swell. Reports redness, swelling, hard, and tender. Redness and swelling is approximately the size of an adult hand. Provider recommending Motrin, ice, and massage.
Patient inadvertently administered 0.25 mL of COVID-19 Moderna vaccine. Patient monitored for 30 minutes after dose administered ; no reactions noted. Patient released home and instructed to report to the emergency room if experiencing any difficulty breathing, generalized swelling, nausea or vomiting.
Shooting pain down arm after lifting a large object after vaccine and once home. Patient reported to us a couple days later and patient is still having issues with tremors, arm pain, and numbness/tinging throughout the vaccinated arm. Patient has stated that the symptoms are improving, but still significant at this time.
Reported to VHC on 10/5/08: 24 y/o previously healthy male with 2 day hx of pleuritic and substernal chest pain (6-7 out of 10), had fever, no dyspnea. On exam he was afebrile with stable vital signs and O2 sat on room air. Temp 98.6 Pulse 86 B/P 99/63 Resp 16. Physical Exam was essentially unremarkable. His primary inoculation site is healing over as anticipated. He had some costochondral tenderness. No s/s of reduced LV function by physical exam. He received INDOCIN 50 mg, which nearly alleviated his chest pain, and he has been doing well since.
I have had a very strong adverse reaction to the first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I have had a very strong adverse reaction to the first shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I have had a very strong adverse reaction to the first shot). At the time of the report, VACCINATION COMPLICATION (I have had a very strong adverse reaction to the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Around 2PM, while at school, patient felt faint and had a near syncope.  He was taken to the ED. He received IV fluids and evaluation.  He went home within a few hours.
I woke up with a fever the morning after receiving my second dose at around 0400. I went and got a drink of water and then went back to sleep. About an hour later I woke up with extreme epigastric pain. I rolled around in pain for probably about 45 minutes, trying to find a way to lay comfortably. I decided to get up and seeing if I could defecate and maybe that would relieve my pain. I was in so much pain and sweating profusely that I was forgetting to breath. I kept telling myself, remember to breath because if not, I am going to die.  when I stood up from the toilet I took a few steps over to the sink where I got light headed. I tried splashing some water on my face to cool off but I got too dizzy and fell to the ground. I think I passed out because I remember laying on the ground for a few minutes and the sink water was still running. Then I got up and walked over to the kitchen and got another sip of water. Still, drenched in sweat, I got dizzy again, knowing I may pass out I found the wall and then a desk, and got as low as possible. I think I hit the ground pretty hard again but did not pass out. I was still in extreme pain at this time. I layed on the living room hardwood floor like a starfish for about 20 minutes because it felt cool. After about 5-10 minutes of that time, my epigastric pain subsided. As I layed in a puddle of sweat I decided I needed to ice my forehead so I grabbed an ice pack from the freezer and layed on the couch. My fever quickly went to chills and after about 10 minutes on the couch I went back to bed to warm up. I never experienced so much pain in my life. I thought I was dying/going to die.
PER WIFE, VOMITED ALL NIGHT, BLEEDING FROM INJECTION SITE, FEVER/SWEATS, VERTIGO
Information has been received from a physician concerning a 14 year old female who on 19-JAN-2009 was vaccinated intramuscularly with a first dose of VAQTA (lot # 658174/1297X) 0.5mL. On 19-JAN-2009 ("once leaving the office") the patient experienced hives. The patient called the physician. At the time of reporting, the patient was recovering. Additional information has been requested.
Headaches, dizziness, lightheaded, nausea, muscle pain, exhaustion