chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given to a 15 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 15 year old) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 15 year old). On 19-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 15 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications details were provided. No Treatment Medications details were provided.
that FLUZONE HIGH DOSE QUADRIVALENT was administered to 3 patients instead of FLUBLOK QUADRIVALENT with no adverse event reported.; Initial information was regarding an unsolicited valid non serious case was received from an other health professional via Agency (Reference number- 00816965) and transmitted to Sanofi on 18-Oct-2021.  This case involves a 54-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included SODIUM.  On 17-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ747AB, expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to wrong product administered (latency: same day).  It was reported that FLUZONE HIGH DOSE QUADRIVALENT was administered to 3 patients instead of FLUBLOK QUADRIVALENT.  At time of reporting, no adverse event 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 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.
5:50 pm urticaria 5 minutes after vaccine right upper thigh welt 2 cm x 1 cm with surrounding pinkness no cough/wheeze or vomiting Benadryl 3.5 ml oral given 5:55 pm small welts on back Prednisolone 6 ml given 6:15 pm right thigh welt resolving, hives on back resolved monitored further and sent home  Referred to allergist for follow-up
Stocking-glove neuropathy, all 4 extremities; This is a spontaneous report from a contactable physician. A 46-years-old female patient (non-pregnant at time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 19Jul2021 (at the age of 46-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included asthma, COVID 19 pneumonia from Jan2021, CVA during COVID hospitalization, hypertension, covid prior vaccination, ophth (disorder). No covid tested post vaccination, no known allergies. No other vaccine in four weeks. Concomitant medications in two weeks included amlodipine; umeclidinium bromide, vilanterol trifenatate (ANORO); atorvastatin; aspirin [acetylsalicylic acid]; brimonidine tartrate (BRIMONIDINE) for ophth; carvedilol; latanoprost for ophth; hydrochlorothiazide; losartan; salbutamol sulfate (ALBUTEROL); montelukast. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on Jun2021 (at the age of 46-years-old) as single dose for COVID-19 immunization. Two weeks after administration of 2nd vaccine dose, on 02Aug2021, the patient reported stocking-glove neuropathy, all 4 extremities. Event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for event including gabapentin 300 mg TID (thrice a day). Outcome of the event was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Neuropathy peripheral  and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient was only given half dose of Moderna Bivalent Booster. Patient was to be given 0.5mcg. Wrong dose given.
Dizziness and passed out for unknown period of time  Fall down form chair and blood came from Nose  Difficulty breathing  Low blood pressure   Ambulance was called at vaccination center and taken to emergency rooms
CHILLS; LITTLE TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and the outcome of little tired was not reported. This report was non-serious.
Because of my arthritis and fibromyalgia, I am used to be achy and in pain. The pain went on for a while I checked with my family DR. I had aches, pains and fatigue more than what I am used to having. I did not have a fever or dizziness. I called my DR after a week of feeling like this after my vaccine. I saw several DRS after my vaccine but I cannot remember exactly when it was so long ago.
Chills, nothing would take them away. Every bone in my body hurt, on a scale from 1 (not so bad) to 10 (bad) the pain was a 10. Fast heart rate, labored breathing. All of these symptoms lasted 24 hours. I had Omnicom and it was not as bad as the booster. I could not do my job. At this time, I am uncertain if anything permanent will come from this.   FYI, although I am a 60 yo female, I run half marathons and am very healthy. This was very difficult to experience.
Patient received vaccine on 4/23.  On 5/05, presented with rash that developed on 5/03.  Plus red erythema of hands, arms, feet.  Papal swelling of MCP joints.  Treated with BENADRYL and ZYRTEC - improving.
I had no reaction to the vaccine at all, not even a sore arm.  Three months later I tested positive for COVID-19.  I had moderate symptoms for about a week.  I'm reporting this in case this pharmacy has a record of mishandling vaccines or the lot number was bad or improperly stored.
After receiving the shot I had an incredible high fever for 2 days. I would randomly get fevers after that. I have been having breathing issues. My menstrual cycle has been off. It has been painful since the vaccine and that's not normal.
1. Elevated temperature 99.5 for 18 hours 2. Body aches for 18 hours 3. Headache on and off for 18 hours These symptoms were relived with Tylenol every 6 hrs for 18 hours 4. HSV2 out break 2 days after vaccination - lasted 3 days and cleared up with usual treatment  Pregnancy date of delivery: 18July2021
elevated blood pressure, garbled speech, TIA Pt presented for acute stroke-like symptoms (L hemibody weakness, dysarthria, L gaze preference, dysarthria, word-finding difficulties) following a COVID vaccination (about 1-15 min after) at 1230 on 3/18/21. PMHx notable for multiple prior TIAa, HTN, HLD, PVD c/b R femoral artery thrombus (2017, no intervention, on Plavix), T2DM (prior A1c 6.5%, recently 6.2% not on meds), COPD, prior splenectomy (childhood re: car accident), chronic L ulnar neuropathy, bilateral hearing loss, complex partial seizure disorder following Rocky Mountain spotted fever. Symptoms resolved fully within 24 hours of event; diagnosed with TIA. MRI without new ischemic findings; chronic small vessel disease and chronic small R cerebellar stroke noted. TIA likely occurred in setting of hypertensive event with systolic BP to 220s. ED attending reported an NIHSS of 9. Of note, blood pressure was in the 210s systolic on admission, and subsequently down trended. Per resident, initially had left gaze deviation however on exam had full ocular motility. Pupils were of equal (size: OD 3, S 3) and reactive. Ocular motility was full without nystagmus. Facial sensation normal. Initial mild left facial droop, which also resolved. As the exam progressed, the patient's symptoms began resolving. Patient was able to articulate his thoughts better without dysarthria and strength markedly improved in the left upper and lower extremities to full 5/5 strength within about 30-45 minutes. NIHSS improved from 9-1. Of note, the patient reported having several episodes similar in nature, in the setting of significant hypertension as well. Denied ever having a true stroke in the past.
Initial unsolicited report received from a healthcare professional on 11-Aug-2015. Manufacturer number: 2015260439. A female patient (age not reported) whose medical history and concomitant medications were not provided had received a dose of TYPHOID VI (batch number, expiry date, dose details, route and site of administration were not provided) on an unspecified date. On an unspecified date, 12 minutes post-vaccination, the patient developed rash, swelling and hives. Laboratory investigations and corrective treatment was not reported. At the time of this report, the outcome of the events was not reported. Documents held by sender: none.
Vaccines given on 8/17/04. Came to clinic  8/18/04 with Pink rash on neck & small bumps in mouth. Swollen eyes. Had fever night before. (Temp.not taken by parent)Temp.98.7 @ 10 AM on 8/18/04 Dr. gave Benadryl 12.5 mg P.O.& Amoxicillin 400mg. bid x 10 days.
painat the injection sight which was her left arm; swelling at the injection sight which was her left arm; redness at the injection sight which was her left arm; got shingles after first shot; blisters on arms, neck, back and chest; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 30th September 2020, 21 days after receiving Shingrix, the patient experienced shingles and blister. On an unknown date, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the shingles and blister were unknown and the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the shingles, blister, injection site pain, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The patient did not have Lot number on the information pharmacy provided or strength. The patient experinced shingles. The three weeks later patient developed blisters on arms, neck, back and chest.   The patient  experienced pain, redness and swelling at the injection sight which was her left arm.   The patient stated that the swelling and pain subsided but the redness stayed for months. The reporter given permission to follow up with HCP (healthcare professional). The reporter consented to follow up.
About 10 PM, I had facial hives and it progressed down to my chest and legs. I had itching. I took Benadryl and Prednisone and it went away. I just one dose of each.
15 min post injection recipient c/o "itching palms, neck and face" while standing in checkout line. No SOB noted or relayed.    Benedryl 50mg administered po. Observed for 30 min and reported relief. Instructed to call personal MD if symptoms return. Instructed to call 911 if trouble breathing or any severe symptoms.   Vitals: BP 100/68. P: 88. R: 16
This spontaneous report as received from a pharmacist refers to a 66 year old male patient with no drug reactions/allergies. The patient's medical history included back pain. On 05-NOV-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported), 0.5 ml, intramuscular for vaccination. Other suspect therapies included unspecified influenza virus vaccine during the same appointment. It was reported that on 05-NOV-2014 the patient experienced severe lower back pain 10 to 15 minutes after vaccination. The vaccines were given in the same approximately 2 inches apart. The pharmacist called an ambulance and the patient was taken away on a stretcher. At the time of reporting, the outcome of the patient was unknown. The patient sought unspecified medical attention. Additional information is not expected.
Vaccine given 2/12/07. 2/12/07 pm redness of L thigh increased today 2/14/07.
Pt recved Hep B vax on 5NOV91 & several hrs following vax pt exp a flushed feeling in face & neck; tx unspecified antihistamine; pt also c/o thinking was impaired; p/ 4 to 6 hrs pt recovered;
This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition, historical medication and concomitant medication. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB, lot # M010671/expiration date-02-JUN-2018, lot no. M026309/expiration date- 11-NOV-2018, lot # M018625/ expiration date- 11-AUG-2018, lot # M023892/expiration date- 15-SEP-2017 and lot no. M028322/expiration date- MAY-2018. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
8/4 - chills, shaking, nausea, headache. 8/5 fever, darrhea, headache, stomach ache, weak, no appetite. 8/8 hive-like welts on face neck. 8/9 rash fading from face but on back, chest, arms, palms.
About 2 minutes after injection patient became pale and he verbally says he is feeling dizzy. I quickly grabbed an ice pack and placed it behind his neck to keep him awake. He started leaning forward and told me he is loosing his vision. He leaned forward and I had to support his chest with my arm all the while trying to talk to him. He dropped his phone and wallet on the floor. He seemed to be loosing conciousness. I had an epinephrine 0.3 mg in my hand but because he was speaking I did not inject him. After about 20 seconds he started gaining his vision back but he said his vision is still fuzzy. After about 2 minutes he felt better so I asked him to position himself at the blood pressure machine. It was 86/65. He does not take any medications or has any health issues. After 10 minutes he took blood pressure again and it was around 129/91. He used the restaurant during the 10 m inute break.
The Pfizer vaccine was kept in the refrigerator past the date of removal/expiration. The patient was notified about the expired dose given, had no signs of an actual adverse reaction to the vaccine, and did end up getting revaccinated on 5/11/22.
Patient came to clinic with prescription from OB/GYN to receive tdap during pregnancy.  Patient received vaccine in clinic and left.  Patient states that about 10 minutes after leaving clinic she started feeling dizzy and had "brain fog" along with an eye twitch and a rash.  Patient also states that she began vomiting and had diarrhea.  Patient went to ED and was given diphenhydramine 25 mg and acetaminophen 1000 mg.  Patient arrived at ED at 1347 and was discharged at 1740.
Illnexx may be unrelated to smallpox vaccine. Pt. reported to ER on 2/27/03 with SOB, productive cough, fever and chills x 2-3 days. Dx with pneumonia w/ pleural effusion. Patient admitted and subsequently transfered to military Hospital on 3/5/03--patient unimproved.
began having symptoms on 09Jan2021 and she had a positive test on 12Jan2021; began having symptoms on 09Jan2021 and she had a positive test on 12Jan2021; This is a spontaneous report from a contactable nurse (patient) reported that a 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on the left arm on 28Dec2020 16:00 at a single dose for safety for herself working with COVID patients. The patient's medical history and concomitant medications were reported as none. The patient asked how she should proceed with her second vaccine dose now that she is positive for covid. The patient received the first dose of the vaccine on 28Dec2020. She was looking for recommendations of what to do about the second dose. She began having symptoms on 09Jan2021 and she had a positive test on 12Jan2021. The outcome of the events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported positive test/having symptoms based on the known safety profile. However the short duration  since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
1wk w/in hr p/vax pt was given pt devel a fever which lasted 48-72hr;
Developed numbness of tongue spreading to periorbital region along with metallic taste in mouth within 10 minutes of injection.  Patient given Loratadine and monitored for 45 minutes.  Symptoms lasted @ 4 hours and resolved.
Patient was recently admitted to hospital from 01/13-1/16 with COVID PNU, was treated with empiric antibiotics and Decadron, was subsequently discharged home on about 6 L home oxygen. His condition worsened and he presented back to the ER on 01/17 with worsening shortness of breath.  Was hypoxic and was placed on high-flow oxygen.  CTA showed right-sided PE, echo did not show any evidence of right heart strain.  He was started on Eliquis, Decadron and empiric antibiotics and was admitted to hospitalist service.  He remained on high-flow oxygen.  He was weaned to nasal cannula on 01/27 and currently on 6L, and wanted to go to specialty hospital. At hospital he spent 26 days,  hewas deemed safe for discharge to the inpatient rehab facility by myself and the specialist(s) on 2/25/2022. subsequently Rehabilitation Hospital from 2/25-3/4. Patient subsequently experienced increased WOB and LOC with declining mental status and was then transferred to hospital.   Initially admitted to mod care with high O2 requirements. On 3/7, CCM consulted for increasing O2 requirement that decompensated overnight requiring intubation. On 3/16/22  Patient became bradycardic and subsequently was found to be in PEA arrest. Family elected to make patient DNR at that time. TOD: 1250.
Information has been received from a medical assistant concerning a 21 year old female patient with sulfonamide allergy, and no pertinent medical history, who on 13-JAN-2010, was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (lot number not reported). There was no concomitant medication. On 15-MAR-2010, the patient received intramuscularly the second 0.5 mL dose of GARDASIL (lot number not reported). On 15-MAR-2010, immediately after receiving the second dose, the patient "fainted and had a seizure". The patient was referred to the Emergency Room for evaluation. Computerized tomography of head performed on 15-MAR-2010 was negative. It was not known if the patient was admitted to the hospital. The patient's outcome was unknown at the time of reporting. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
After receiving  the booster I started feeling dizziness and light headed and it is still going on. My doctor said that it is vertigo.  It's not as bad as it was when I first got the vaccine. I talked to my doctor virtual and she told me that she didn't want to prescribe me anything and to go to the ER. They ran a round of test on me. ER doctor didn't prescribe me anything. I went to my PCP and she prescribe me, Meclizine 25 mg.
Sneezing and slightly runny nose (like seasonal allergy) started at the end of day 7 after vaccine; morning of day 8 noticed 3-4 inch sized rash on arm and some tightness of skin below injection site on left arm. A little itchy and relieved by ice pack. Still there morning of day 9.
First injection (1/12/21) and second injection (2/9/21) both with similar side effects, however after the second, they were profoundly worse. Immediate dizziness, fever, body aches, piercing abdominal cramps, nausea, and emesis episodes. Immediate then chronic horrible "orbiting" headaches that felt like 1,000 knives piercing my brain- severe headaches, fatigue, lethargy, brain fog, vaginal bleeding, new dx female reproductive virus diagnosis 3 months after 2nd injection, shortness of breath, rapidly increasing heart rate with minimal exertion, impaired neurological and pulmonary function. I'm a marathon running and multi Marathon Qualifier; my training and competition capabilities have been profoundly impaired.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 06-JAN-2014, 06-MAR-2014 and 07-JUL-2014, the patient received the first, second and third doses of GARDASIL for prophylaxis (strength, dose, route, lot # and expiration date were not reported), respectively. Then, on 24-NOV-2017, the patient received an extra dose of GARDASIL 9 for prophylaxis, lot #N021571, expiration date on 29-APR-2020 (strength, dose and route were not reported). No symptoms were reported.
Case number PHEH2014US024368 is an initial spontaneous report from a nurse received on 02 Dec 2014, with a follow up received from nurse on 19 Jan 2015. This report refers to a 79 years old female patient. Her medical history was not reported. Concomitant medications were none. The patient had tolerated the vaccines well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml into the right deltoid on 06 Nov 2014. The nurse reported that before vaccination the prefilled syringe of FLUVIRIN was stored at 49 degrees F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the maladministration. Follow up received from nurse on 19 Jan 2015: updated site of vaccination and reporter comment.
Headache, HYPERtension, Angina, malaise Narrative: employee has history of Afib and HTN. Went to ER on 1/28/2021 and is undergoing MI workup. Still there as of 1/28/2021@1100