chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient arrived to ED with itchy throat, facial swelling and erythema and tachycardia. Patient was given Benadryl and Pepcid (dose and route unknown), and sent home with a prescription for Methyprednisolone 4 mg dose pack and Ventolin for home use. Patient reports reactions to other medications in the past, having an extensive allergy list.
Patient received vaccine on 9/29/15. She returned to the pharmacy on the second week of January stating that since the injection, she has had arm pain when moving or bending her arm. She consulted a physician who speculated that the needle hit a muscle fiber. She is currently undergoing physical therapy. (Right arm).
Elevated blood pressure ~30-40 higher than normal systolic and ~10-20 higher than normal diastolic for 4 days following vaccination.  Values gradually descending towards normal on days 4-6.  Max measured resting BP was 161/101.  Accompanying headaches, neck, back, and shoulder pains may have been related.  Occasional "dizziness" at times assumed to be higher BP occurrences.
Woke up in the middle of the night with hives, gone the next day. Didn't take anything for the hives
30 minutes after the shot I started to feel numbnes and hot on left of my face and ear.  It didn't really worried me at that time because I thought it is normal and it will go away. It didn't go away and I felt hotness around my face ear, and my hearing in my right ear was slighly worse, including some pain in the ear. First time I contacted my family doctor 4 days later when the symptoms got worse. My dr told me to use Ibuprofen 600 3 times a day for 3 days. After I didn't see any improvement I scheduled the appointment and saw my doctor 8 days after the vaccination. My doctor said my ear is clear and there was no infection and she gave me different antinflamatory medicine to take it for a week tis time. She didn't think that was from  the vaccine though. After a week It seems that I felt better but still not completely recovered. I stopped taking this medication after a week as descibed. the sympthomcame back and now I'm 16 days after the shot and 6 day before the second dose and I'm scared what to do.
Information has been received from a physician concerning a 15 year old female with a penicillin allergy and no pertinent medical history who on 16-AUG-2007 was vaccinated with a first dose of Gardasil (lot# 658558/1061U) in the left deltoid IM.  There was no concomitant medication.  On 17-AUG-2007 the patient experienced significant nausea, vomiting and diarrhea.  The events started one day after vaccination.  Medical attention was sought.  The patient was seen by the primary care physician on 24-AUG-2007 for evaluation, secondary to persistent symptoms, was told to keep hydrated.  At the time of reporting it was unknown if the patient recovered.  Additional information has been requested.
Left auricle swelling and redness with onset 2 days post injection associated with chills, fatigue without other rash, tenderness, fever, or other symptoms.  Examination 5/2/2021 revealed nontender, swollen auricle without exudate, no induration, no evidence of infection, no other rash.
Fever, injection site swelling, redness inflammation, 24-48 hours post injection.
On 2/14/03 at 8:45am Mother brought patient into our office to look at his reaction to the shots on his right thigh. Approximately one inch later to each injection puncture a pea size on upper and a dime size area of redness with warmth noted on lower injection site lateral to the puncture site. Doctor evaluated right thigh 2/17/03. Dx: mild cellulitis right thigh. Prescribed Ceclor 250/5cc  tsp bid for 10 days given.
Pt looked palor, felt very dizzy and fainty. Pt was assisted to sitting/lying position to help elevate blood pressure. Pt mother and a friend trauma nurse, were present at scene to provide child with first aid care. Pt recover after 15-20 minutes and color return to face.
About a week after the vaccine I had welts all over my body. They were like the welts that I had when I had Covid-19 in July of 2020. The welts came and went for a while and they were mainly on my left side. I woke up with them and then they would come and go during the day. They were hard raised welts and it lasted for three weeks. I also seemed to have allergic reactions to some foods. I went to the ER on 04/29/2021 three weeks after the vaccine. The welt on my wrist was very red and swollen and I was concerned. I was prescribed an antihistamine. It helped with the rash and other symptoms.
walking on it was difficult; lower leg felt like it was cold; like a cramp was going to set in, but it didn't; leftover nerve pain..really bad; Chills; generally feels run down; Hives; Headache; Lower back pain; Thumb, pointer, and middle finger on the right hand went extremely numb and painful; felt a tight headband on my head; A spontaneous case report sent by a Other on 25-JAN-2021 from, which refers to a Female aged 53 Years.  On an unknown date  the patient received Moderna COVID-19 Vaccine for the prophylaxis of COVID-19 vaccination. Some    later,  the patient developed walking on it was difficult, the patient also developed Lower back pain,felt a tight headband on my head,Thumb, pointer, and middle finger on the right hand went extremely numb and painful,Headache,Chills,lower leg felt like it was cold,Hives,generally feels run down,like a Charlie horse was going to set in, but it didn't,leftover nerve pain that was really bad on that day.  Relevant laboratory details were unknown.  Relevant concomitant medications were none.  The patient was treated for the event with IBUPROFEN,BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE],ZYRTEC ALLERGY  for hives. The oncologist did not declare any relatedness between walking on it was difficult and Moderna COVID-19 Vaccine..  The clinical outcome of  leftover nerve pain was Unknown,walking on it was difficult was Unknown,like a Charlie horse was going to set in, but it didn't was  Unknown,generally feels run down was Unknown, Hives was  Unknown,lower leg felt like it was cold was Unknown, Chills was Unknown, Headache was Unknown,Thumb, pointer, and middle finger on the right hand went extremely numb and painful , which lasted couple of hours was Recovered/Resolved,felt a tight headband on my head  was Recovered/Resolved,Lower back painIt was there for about an hour and then it was gone  and was Recovered/Resolved.   Causality was not provided between the suspect drug and the events.
Gave flu shot LD & ZOSTAVAX SQ LA on 10-24-12 at around 1630. Within 6-7 min, I received a call stating that she could hardly breathe. They were back in the parking lot & I ran down & gave EPI SQ & BENADRYL 50mg IM.
Rash for a few days/Covid arm; Painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Painful) and VACCINATION SITE RASH (Rash for a few days/Covid arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 629K20A) for COVID-19 vaccination.     The patient's past medical history included Breast implant rupture, Itching and Fibromyalgia. Concomitant products included SIMVASTATIN and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (Painful). On 05-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash for a few days/Covid arm). At the time of the report, VACCINATION SITE PAIN (Painful) had not resolved and VACCINATION SITE RASH (Rash for a few days/Covid arm) had resolved.            No treatment information was provided.  Patient took second dose on 22 Feb 2021.   This case was linked to MOD-2021-239042 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Ethnic group was updated. Medical history added. Concomitant medication were added. Vaccine facility name, covid vaccine second dose details were updated.
nearly immediate local erythema and itching at Hep A vaccine site, extended over entire deltoid area, patient described chest "felt heavy" - given diphenhydramine with resolution of itching, "heavy" chest feeling nearly resolved after approx 90 min,  no stridor, BP, pulse, RR remained normal - discharged home after 2 hours on benedryl, prednisone, cimetidine, patient was asymptomatic 3 hours later - no local reaction at Menactra site L arm
On 10/09/2023 we received a notification from GSK about a documentation issue with a specific  Arexvy lot (P5572). Product on quarantine
Patient stated his age is (21 y) for first dose. When he came back for 2nd dose due to insurance we found his birth date to be only (16y and one month). After consulting with CDC guide line and ok from his legal guardian he will get 2nd dose soon.
shoulder soreness can barely lift her arm; Muscle soreness; Bothering joints and fingers; Bothering joints and fingers; This is a spontaneous report from a Pfizer Sponsored Program received from a contactable consumer reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. Medical history included osteopenia from an unknown date 10 years before this report. The patient's concomitant medications included risedronate sodium (ACTONEL). The patient reported that after first shot, she had shoulder soreness and could barely lift her arm. She stated she felt muscle soreness and had bothering joints and fingers and stuff. The events outcome was unknown at the time of the report.  Information on Lot/batch number has been requested.
This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 4-month-old unk patient who received KINRIX. On an unknown date, the patient received KINRIX at an unknown dose. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to KINRIX.
On 4/5/2021(Monday) patient received vaccine approx. 2pm. Patient noted at 11pm their throat was closing and rash. Patient went to ER but did not wait and decided to take benadryl which help her symptoms. Patient called the Pharmacy 4/9/2021 (Friday)  at 6pm and informed us of side effects she was experiencing and stated her throat/skin was itching and hard to swallow . I told her to take benadryl immediately and go to the ER.
Within 24 hours of my second dose of Pfizer vaccine I?ve got rushed to the emergency with loss of feeling and numbness on my right side face where I was diagnosed with Bell?s palsy
Febrile seizure 1/10/2021 Viral rash 1/13/2021
Body aches; pain; hardness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), VACCINATION SITE PAIN (pain) and VACCINATION SITE INDURATION (hardness) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (Body aches), VACCINATION SITE PAIN (pain) and VACCINATION SITE INDURATION (hardness). At the time of the report, PAIN (Body aches), VACCINATION SITE PAIN (pain) and VACCINATION SITE INDURATION (hardness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Patient had immediate Syncope, but was conscious through out the recovery process. Did say that he couldn't see anything. Pupils were dilated.  Suggested rest and called EMS. Patient regained normal breathing and pulse by the time EMS arrived at the pharmacy. Followed up with patient later in the day. Everything back to normal.
The day of the vaccination, the pt developed extreme dizziness that lasted 36 hrs with nausea and flu-like symptoms that lasted three days.
This spontaneous report was received from a healthcare worker and refers to two patients of unspecified age and gender. On an unknown dates, the patients were vaccinated with doses of GARDASIL (0.5 ml, intramuscularly, anatomical location, lot# and exp.date were not reported) that underwent a temperature excursion. no adverse effect was reproted. The outcome of the event was unknown. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA experience a slight increased heart rate to about 101 2 min after injection and then another heart rate increase to 120 about 15 minutes after injection. Heart rate was back to normal about 5-10 after spike but patient stayed for observations for another 30 min.
I received the second dose of the COVID-19 vaccine on January 13, 2021. In early March, I began experiencing some health concerns. I have a history of Dysautonomia and Anxiety. The dysautonomia has been controlled with lifestyle modifications for over 5 years. Symptoms experienced with it include low blood pressure, tachycardia, pre syncopal feelings and syncope. The occurrence of these symptoms became more frequent after receiving my second vaccination. In addition to above symptoms, my anxiety has worsened (which has been well controlled on the same medication for over 5 years), more syncopal episodes, acute weight loss, increased fatigue, lower baseline blood pressure, hair loss, temperature instability, and intermittent chest heaviness.   In June, I had a dental procedure in which local epinephrine and lidocaine was used.  I drove myself as I was told this would not be an issue since nitrous or general anesthesia was not used. I left the appointment to drive 20 minutes home. Within 5 minutes of my house, I began with pre-syncopal feelings (dizziness, blurred vision, pounding headache). I pulled off on side of road and within seconds, I had loss consciousness. I was by myself so unsure as to how long before I regained consciousness. When I woke up, I notified  my spouse. I noted that I had loss bowel and bladder control during this episode, which has never occurred during my syncopal episodes. My foot was also cut from the foot pedals. My spouse said it took approximately 45 minutes for me to return to baseline. This episode was concerning for seizure activity, in which I will be evaluated by a Neurologist. I have no history of seizure activity. I have been evaluated per my primary and cardiologist. Cardiology believes my dysautonomia has worsened and is being exacerbated and feels as if this may have caused a rebound reaction to the local meds.   But why now? Why is my dysautonomia worsening when I'm an otherwise healthy, young adult.
Fever on 9/13/00 at 02:00 to 101F, relieved by Tylenol but child was extremely tired and lethargic. Mom states she carried him into doctor's office on 9/13/00. Temperature spiked again on 9/14/00 to 102F; gave Tylenol and bath to decrease temperature. Mom state child was "overly tired" over entire summer. Temperature elevations down since 9/14/00.
Arm has been sore; Chills; when she administered the vaccine she squirted the vaccine on me; nurse then drew up additional vaccine and administered 0.3mL; A spontaneous report was received from a consumer concerning a 42-year-old, male patient who was participating in the mRNA-1273 Emergency Use Program and experienced accidental underdose, extra dose administered, arm has been sore and chills.  The patient's medical history not provided.  Concomitant medications not provided.  On 16-JAN-2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The patient reported that when he received the vaccine, the nurse squirted some of the liquid on him.  He stated that she then went and got more vaccine and administered an additional 0.3mls.  Additionally, he stated that on 17-JAN-2021, his arm was sore and he had chills.   Treatment included Aleve.   Action taken with mRNA-1273 in response to the events, accidental underdose, extra dose administered, arm has been sore and chills, was not provided.  The events, accidental underdose and extra dose administered, were considered recovered/resolved. The outcome of the events, arm has been sore and chills, was unknown.; Reporter's Comments: This case concerns a 42 year old, male patient, who experienced a non-serious expected event of vaccination site pain, and chills, 2 days after receiving 1st dose of mRNA- 1273 (Lot# Unknown). This report also refers to a case of wrong technique in device usage process and accidental overdose for mRNA-1273 (lot # 028L20A), with no associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Numbness to (R) hand - started approximately 1 day after vaccine and lasted around 2 wks.
Welt at vaccine site, quarter-sized, gradually diminished over course of 2 months, right thigh. Had projectile vomiting for 24 hours, uncontrolable crying for several days, refusal to nurse for several days and insomnia for 2-3 weeks.
Itchy rash started on 9/16/11. Fluid filled lesions on ankles & spread to trunk, arms, neck, chest and axilla, treated with Valacyclovir.
Patient exhibited a forceful cough for a few minutes after receiving vaccine.  RN talked with patient through care giver as patient does not speak English, as well as an on site interpreter.  Patient described feeling "dizzy" and "sleepy" .  patient's care giver described the patients' history of absent seizures brought on by panic attacks. In this anxious state, patient was tachycardia, hypotensive, and tachypneic.   RN monitored patient as she lost consciousness for about 7 minutes.  in this state, patient was unresponsive with normalized heart rate and respiratory rate.  Blood pressure was measured when patient was out of consciousness and was hypotensive.  Patient began to regain consciousness after about 7 minutes and was oriented to person, but not place or time.  Care giver insisted on not calling for an ambulance and he would take her home.  Patient was given 16 ounces of water and vitals monitored for about 20 more minutes until patient was normotensive and orientedx3 and was discharged to home with care giver.
Information has been received from a physician concerning unspecified number of unspecified patients. On unspecified dates since 30-JAN-2015, the unspecified number of unspecified patients were administered an unspecified number of improperly stored doses of RECOMBIVAX HB (dose, strength and lot# were not reported, intramuscularly). No adverse effects were reported. This case was one of the three cases received from the same reporter. (Other two case were 1504USA002465 and 1503USA010732). Additional information has been requested.
tingling on the left side of her face below her eye and lower half of her face/facial tingling on the left side of her face; This is a spontaneous report from a contactable Consumer (patient) A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 at single dose in her left arm for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On 28Jan2021 patient noticed facial tingling on the left side of her face below her eye and lower half of her face. The final outcome of the event was unknown.Patient would like to know if her symptoms were normal and would like to know what she should do about her symptoms. She wanted to know if she should be worried about that and if it was a known side effect. information on the batch number has been requested
Approx 5-10 minutes after administration of 2nd Pfizer vaccination, employee became very very pale and complained of feeling faint.  Auscultation of lungs revealed clear to all fields and heart sounds revealed an irregular rhythm.  Assessed if employee had ever had a cardiac issue in the past and employee stated that nothing was known.  Employee continued to be near syncopal and EMS was activated.  Upon their arrival, EMS also noted the irregularity and offered to transport employee to ER for further evaluation.  Employee refused to go to ER.  Monitoring of employee by facility staff continued for approx 40 minutes longer and condition did improve but did not resolve.  Employee admitted having vertigo and some nausea but refused to be taken home or go to ER despite much encouragement from nursing leadership and supervisor.
Patient had no reaction at the time of vaccination. Waited the required 15 minutes and was allowed to go home.
Problem: Patient was given the incorrect dose of 0.5 mL for Moderna Booster in Drive-thru Vaccine Clinic. Nurse was given the incorrect dose dispensed by the pharmacist. This inadvertent incident happened due to a lack of communication in training given to the Nursing staff from the Pharmacy team.    Corrective Action: Nursing and Pharmacy has since been given a vaccine dose chart with correct dosing amounts listed for Moderna, Pfizer and Johnson & Johnson vaccines. Second, trays have been given to both teams to separate vaccine doses to prevent future error events.  Lastly, Pharmacy is only preparing the Pfizer vaccine since it is standardized to 0.3 mL presently. Going forward, Pharmacy and Nursing will continue to work together to maintain open communication.  All patients were notified of the incorrect dosing and given an opportunity to be seen in clinic by a provider if they remained concerned.
STABLE ANGINA ACUTE NON ST ELEVATION MI 2/6/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Resting heart rate 113, lasted about 12 hours. Improved after that point however it is still elevated and increases rapidly with minor activity.  High fever -103.9F
Patient received the Pfizer Covid vaccine number 2 and about 15 minutes after the dose began itching and showing some raised red hives on arms and scalp and a little on the back.   we administered Benedryl 50mg IM and within about 10 minutes itching decreased and no additional symptoms have arrisen
A non-serious report of administration of expired FLUMIST was received from a healthcare professional concerning a 21-year-old male.  The patient's medical history and concomitant medications were not reported.  On 06-Oct-2008, the patient presented at the base clinic and received FLUMIST via nasal administration by an immunization health technician.  The vaccine was found to be expired (expiration date 24-Mar-2008).  The expired lot of FLUMIST was given to 17 adult individuals including this patient.  The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.  Follow-up information was received on 09-Apr-2009:  Product Complaint Investigation results.
fever to 105.0 11PM;Incessant crying, fussiness-AM afternoon & noc;tx APAP;