chrisvoncsefalvay/vaers-outcomes huggingface dataset:
paralyzed from  mid back down; Initial information was received on 11-Nov-2020 regarding an unsolicited valid serious social media  case from the non-health care professional   This case involves a female patient of unknown age who paralyzed from her mid back down (paraplegia), after she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient paralyzed from her mid back down (paraplegia), (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  Information on batch number requested.; Sender's Comments: This poorly documented social media case concerns an patient of unknown demographic who had paraplegia after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Also, the patient's medical condition at the time of vaccination, concomitant therapy and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
hives/itching, headache, fatigue,  joint pain, still have headache and fatigue, itching is gone.
Information has been received from a physician concerning a female patient who on 08-JUN-2009 was vaccinated with a single dose of ZOSTAVAX (Merck) (Lot number 663779/1791X), 0.65mL. The physician stated that the patient received ZOSTAVAX (Merck) and recently came down with a case of shingles. At the time of the report, the patient had not recovered for shingles. The patient sought unspecified medical attention. Additional information has been requested.
Pt called and complained of swollen red painful arm where the Pneumovax shot was given.
23AUG91 pt recvd an Engerix-B vax & 24AUG91 devel vertigo which lasted for 1 day & resolved w/o treatment; 23SEP91 recvd a 2nd vax w/no recurrence of vertigo;
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 23-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
After receiving 2nd vaccine shot in early AM, felt great throughout the day.  Around 9:30pm, I started experiencing shivers that turned into the worst shivers that I've ever experienced throughout my entire body.  I could barely function, hands/arms/feet/fingers were shaking - even my jaw was uncontrollable clacking up and down.  At the peak, this transpired into an intense headache in the upper back part of my head that scared me to death, it was severely intense to the point I thought I was having a stroke or something.  My head pounded all night and also my body felt like needles were poking me in every joint in my entire body.  Sleeping was miserable and minimal and symptoms are continuing the next day but not as severe.  Lots of body pains and a constant headache.  Resting and drinking water to try and remedy.
Ringing in ears/tinnitus in his ears/popping sound in his ear/after that the ringing started, the sound goes higher and lower; Popping in ears, after first vaccine; 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.  A male patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 22Apr2021, outcome "unknown", described as "Ringing in ears/tinnitus in his ears/popping sound in his ear/after that the ringing started, the sound goes higher and lower"; EAR DISCOMFORT (non-serious) with onset 22Apr2021, outcome "unknown", described as "Popping in ears, after first vaccine".  Additional information: Patient received the first dose of the Pfizer Covid 19 vaccine on 22Apr2021. 18 hours later he hear a pop in his ears but didn't think much of it.  He now has ringing/tinnitus in his ears for over 2 weeks. The ENT has confirmed he has no hearing loss and he was the first patient he has had present with tinnitus after the vaccine. His audiologist states he has had other patients with tinnitus after the vaccine. States he was calling about the Covid vaccine, and confirms the Pfizer Covid vaccine. Reports that he got the first dose over 2 weeks ago, on 22Apr2021. States he has seen an ear, nose and throat doctor and an audiologist. States that the audiologist reported that he had no hearing loss. States that the ear, nose and throat doctor, gave him no information on what he should do about the ringing. The doctor did not tell him if he should take medications like steroids, or if the ringing in his ears, will be temporary or permanent. States that the doctor did not tell him what to do about taking the second dose of vaccine. Reports that the popping sound in his ear, had equalized and went back to normal. States after that the ringing started, the sound goes higher and lower, and has lasted for two weeks. States that he just wanted to report his event and to see if Pfizer had any information about the side effect of tinnitus. States that he went online and found a social media group about people that had tinnitus, after the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Soreness at injection site, fever, headache, body aches and pains, fatigue
Patient received 1 additional series; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 23-Mar-2022 Reporter's Comments: Pharmacist submitted a  inquiry so a patient might have received an additional series of the Shingrix vaccine. Additional Supportive Information: The patient might have received an additional series of Shingrix vaccine, which led to extra dose administered. The reporter did not consent to follow up.
Fifty cent size edema and redness around injection site. Advised cool compresses, Benadryl. Call back if symptoms increased.
arm really hurt; slight fever; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (arm really hurt) and PYREXIA (slight fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Colon cancer.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm really hurt) and PYREXIA (slight fever). At the time of the report, VACCINATION SITE PAIN (arm really hurt) and PYREXIA (slight fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The patient was running late for her chemo appointment. She was going into getting her colon operated on, so she wants to make sure she does not get COVID when she was in the hospital.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-347431 (Patient Link).
Having a heart attack; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Having a heart attack) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Having a heart attack) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDIAL INFARCTION (Having a heart attack) outcome was unknown.            No concomitant medications were provided.  Treatment medications was not provided.  Very limited information regarding the events has been provided at this time; Sender's Comments: Very limited information regarding the events has been provided at this time
1 week after vaccination, developed hives on face, arms and torso 2 days in a row - late afternoon. Relieved with BENADRYL.
Bilateral pulmonary emboli. Treated with Eliquis. Currently stable, but overall outcome TBD.
Information has been receiving from a registered nurse concerning a 15 year old female with no medical history who on 19-JUL-2006 was vaccinated in the right deltoid with the first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653937/0637F).  Subsequently, on approximately 19-JUL-2006, the patient experienced burning at the injection site that lasted approximately 60 to 90 seconds and her arm became red and painful enough to cause the patient to cry.  The patient subsequently recovered from the pain in the extremity, erythema, and injection site irritation.  Additional information has been requested.  The registered nurse also reported that the patient's sister experienced pain in the extremity, erythema, and injection site irritation following vaccination with HPV rLi 6 11 16 18 VLP vaccine (yeast) (LOT#653937/0637F).
This spontaneous report was received from a healthcare student refers to a male patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, route, lot# were not reported) to prevent shingles. On an unknown date, after this, the patient received a blood transfusion for an unspecified reason. On an unspecified date, after this, the patient developed shingles. Patient sought medical attention by calling pharmacist. No Product Quality Complaint (PQC) was involved. The outcome of the events was unknown. Causality was not assessed by the reporter. Additional information has been requested.
Only liquid portion of Menveo; Patient only received  diluent; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 20-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA660A, expiry date 28th February 2023) for prophylaxis.   On 25th August 2022, the patient received Menveo (intramuscular). On 25th August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-Aug-2022 Reporter's comment: The pharmacist reported that the patient only received the diluent (liquid conjugate) portion of the Menveo vaccine. Additional supportive information: The patient received only diluent of Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
This spontaneous prospective pregnancy report was received from a Registered Nurse regarding a 19 year old female patient. The patient has no medical history and concurrent conditions. On an unknown date in 2002, patient was vaccinated with first dose of VARIVAX (Merck) lot details unknown, 0.5 milliliter (ml) subcutaneously. On 27-APR-2016, the patient was vaccinated with second dose of VARIVAX (Merck) (lot # L030158, expiry date 11-AUG-2017), 0.5 ml, subcutaneously (Inappropriate schedule of vaccine administration). On 29-APR-2016, the patient was seen at health department to obtain unspecified birth control and urine pregnancy test was positive. Nurse reported that patient was in good health. The last menstrual period (LMP) was reported as 03-JAN-2016. Estimated date of conception was 17-JAN-2016 and estimated date of delivery (EDD) was reported as 09-OCT-2016. The pregnancy outcome was pending and fetal outcome was unknown. It was reported that no treatment was given for the event. Additional information has been requested.
11/20/16 Headache, pressure, sick to stomach, achy, Rt arm hurts, red, swollen at site. 11/21/16 slept all day/lethargic, achy. -
Information has been received from an LPN concerning a 7 year old white male with no known drug allergies who on 7/18/96 at 10:00 AM was vaccinated with a 1st dose of varicella virus vaccine live in the right arm (lot 617072/1661B). On 12/18/01 at 3:00 PM, the pt presented with chicken pox. The pt had a low grade fever and approximately 33 lesions. The pt's lesions lasted approximately 4 days, then scabbed over. The pt subsequently recovered. At the time of this report, the pt was "fine". No additional information is expected.
No adverse event occurred.  Child received RotaTeq dose #2 at 37 weeks of age which was outside of licensing guidelines.
I had a burning feeling in my chest. I also had a fever, cough, fatigue, and a sore throat. These lasted for about 11 days. I was tested positive for Covid-19 on Jan 12th.
Patient reported pain an difficulty with full range of motion of arm, two months after administration (10-1-15). Patient believes vaccine administered too high up on shoulder. Pt advised to see MD, but thus far has chosen not to.
Patient was vaccinated on Friday March 22nd, and broke out in a severe all body rash on Sunday the 24th of March.
This is a spontaneous report from a Pfizer-Sponsored Program, Pfizer RXPathways. A contactable pharmacist reported that a 74-year-old female patient of an unspecified race received PREVNAR 13 (lot R19477, expiry date Jan2018, NDC number 00005197102) on 06Feb2017 at 0.5 ml single for immunisation. The patient was diabetic. Concomitant medication included gabapentin, 300 mg, 3x/day. On 11Feb2017 the patient was having a reaction around the vaccination area described as: hot, itchy, pain, red. Pain and itchiness were going down to the arm every day and it was all down to the elbow at the time of report. As treatment the patient took some paracetamol (TYLENOL) and then levocetirizine (XYZAL) which was not helping. All these events had not yet resolved at the time of report. The reporting pharmacist also stated that nobody prescribed her PREVNAR 13. Laboratory test: none. The reporter considered that the events were related to the suspect vaccine and added that even though it was a delayed reaction and vibrating all the way down, did not think it was due to an injury that she had recently.
Blister formed in vaginal area. Broke open. Rash developed along right buttock. Burning. Slightly itchy. Symptoms started on 1/25/21. Used Calamine lotion. Presented to clinic on 2/1/21. Diagnosed with Shingles. Started on Valtrex 1gram.three times a day x 7 days
petechia on legs-open sores on buttocks & arm & chest hurts;  legs ache-fever-heart racing, sick to stomach reported by MD;
Sore arm and headache within hours of shot. Days 1-2 included partial numbing of face, shoulder, arm and hip and leg on injection side of body.  Shoulder pain and moderate to severe arm (shoulder and elbow) pain ongoing through three weeks. Grip strength is significantly weakened. Face and ear area are still partially numb through 3 weeks.
"Putting things to throat" (pacifier, spoon, hand), fretful, unbalanced ("falling more than usual")
Narrative: Patient contacted telephone triage nurse today requesting advice. Patient states he had first covid vaccine @ 8:15 am today, "And I think I'm having a very bad reaction to it." He is crying on telephone. Patient states he does not feel right, "I'm very disoriented, something is really wrong." Pt is also c/o severe nausea, "horrible leg cramping in my calf areas, and it feels like my mouth is starting to swell up." Denies difficulty breathing or difficulty swallowing at this time. Patient is seeming very anxious, stated he lost time this morning and doesn't even remember what time he received the vaccine. Also has a headache. States he received vaccine and was en route back home when he couldn't remember how to get home. This nurse recommended pulling over and calling 911, patient states he is just a few minutes away and would prefer to drive, against nursing advice. This nurse stayed on the line with him until he arrived, 9 minutes later. He pulled into ER, this nurse spoke with registration to inform of patient need for emergent care(gave brief report). Patient was immediately taken back by staff for urgent assessment. Please follow up, thank you.
Large red swollen injection site. Fautigue, chills and joint pains, swollen lymph node in armpit
Potential AE due to doses administered from vials that may have been compromised.; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion. Coding; Administered vaccine from vials that may have been compromised.; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion. Coding) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion. Coding) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised.). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion. Coding) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The Moderna date ordered was 01-Nov-2021 and 15-Nov-2021.The beyond use date (BUD) was from 01-Dec-2021 to 15-Dec-2021.  Concomitant medication list was not provided.  It was reported that they were aware in some of the freezers there was a temperature excursion that their data logs shows. The vaccines had never reached a temperature that was considered outside of frozen recommended range. it was reported that they stored them in the freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.   Treatment information was not provided.
Information has been received from a physician concerning a 14 year old female patient who on 20-MAY-2008, was vaccinated with the first dose of GARDASIL vaccine (yeast) and the second dose of GARDASIL vaccine (yeast) was given on 22-JUL-2008. The patient had a lesion removed from her scalp (the lesion was present prior to starting of the HPV vaccine series). When the plastic surgeon requested to have additional margins of the lesion area of the scalp removed he performed a complete blood count on 22-JUL-2008 that showed a platelet count of 40.000. A diagnosis of thrombocytopenia was given. A repeat complete blood count was performed on 24-JUL-2008, and that showed a platelet count of 42.000. The physician mentioned that he spoke with the pathologist performing the complete blood count/manual smear review and was told that the smear was normal. The patient's thrombocytopenia persisted. Additional information has been requested.
Information has been received from a registered nurse concerning a 15 year old female who "2 weeks ago," on approximately 29-MAY-2007, was vaccinated with hepatitis A virus vaccine inactivated (lot #656316/1282F) and became very anxious, dizzy and shaky, but did not faint (determined by nurse to be non-serious events). Subsequently, the patient recovered from very anxious, dizzy and shaky. The product quality complaint unit was not involved. Additional information has been requested.
Fever x 1 day on 11/13/04 rashes noted by parents on 11/17/04 starting on the face and neck, trunk.
About 8 hours after administration, I got severe muscle aches and chills, such that I was shivering uncontrollably for a few hours, not sure how long. Hurt like nothing I?ve ever experienced before. Considered going to a hospital but couldn?t think of how bc I wasn?t thinking straight. It got a little better around midnight and I could get up enough to take some Advil (I had before when I first felt it coming on), had an intense migraine for the rest of the night but migraines I can deal with. Now I?m just a little dizzy and sore. But that was the worst.