chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell's Palsy; This spontaneous report as received from a consumer refers to a male patient of unknown age. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.    On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route and site of administration, lot# and expiry date were not reported) for prophylaxis.  On an unknown date, the patient experienced Bell's Palsy. The outcome of Bell's Palsy was unknown.   The causality between the event Bell's Palsyand zoster vaccine live (ZOSTAVAX) was not provided.   Upon on internal review, Bell's Palsy was considered to be medically significant.
Initial case report received from a nurse via agency, on 03 DEC 2009. A patient 48-year-old female was vaccinated with FLUVIRIN (batch no. 1009232P) i.m. on 25 NOV 2009. On 01 DEC 2009, the patient experienced tinnitus, erythema and induration at the injection site, a rash on her chest, and impaired mobility of her arm and shoulder. These events were reported as not recovered. On the same day, the patient experienced vomiting and shortness of breath. The events were reported as recovered. Agency reference no.: NA09-009131.
Staff reported a mild tingling in right hand (of injection arm). The tingling lasted for a short period of time and went away once he put his hand in a neutral position.  No other signs/symptoms reported when assessed by the onsite MD. Patient was advised to avoid heavy lifting  and to seek medical attention if symptoms worsened.  Mild to no residual tingling noted at close of observation period (30 minutes).
Information has been received from a physician concerning a female who on 05-SEP-2007 was vaccinated with Zostavax (Oka/Merck) instead of Varivax (Oka/Merck) (MSD).  The physician stated it was just a human error.  On 13-SEP-2007 additional information was received from the nurse at the physician's office.  The nurse indicated that the patient was born in 1979 so she was 28 or 29 years old.  The nurse was not the one who gave the patient's injection.  The patient was given a prescription by the physician for Varivax (Oka/Merck) (MSD).  The patient took the prescription to the pharmacy.  The physician received a call from the pharmacy indicating that they had Varivax (Oka/Merck) (MSD) and questioned if the physician wanted the pharmacy to give that to the patient.  A new prescription was faxed to the pharmacy.  The patient filled the prescription for Zostavax (Oka/Merck) and she was vaccinated with the Zostavax (Oka/Merck) at the physician's office.  The patient read the product circular and realized she had received the incorrect vaccine.  The patient was concerned because she will be trying to get pregnant.  There was no adverse event.  No further information is expected.
Information has been received from a female patient in her "mid 30's" with a history of Crohn's disease. In October 2010 ("last week"), her baby received ROTATEQ orally. "With hours" of her baby receiving the vaccine, she began experiencing fever and diarrhea. Potential vaccine virus transmission was noted. The patient sought unspecified medical attention. Diagnostic determination for Rotavirus was performed (result not provided). Outcome of the events were not reported. There was some discrepancy between what was reported to the pediatrician and the patient's gastroenterologist. Additional information has been requested.
Pt became fatigued 3 hours post immunization. He then noted chills and lightheaded. He feels better today. Exam reveals temp of 100.3, otherwise nl.
Pt. called in with a complaint of a rash on her neck that started on 1 side of her neck and then switched sides. It did not start until well over a week after vaccination and patient says she never had a local reaction.
6 PM at home, felt weak, hot, dizzy, and aching. Left arm numbness. 1st time she had the flu shot. Recovered by 11/9/05.
Patient has history of passing out after vaccines and blood draws. 10 min after vaccine administration patient passed out twice and almost passed out a third time, HR and BP were being monitored and were low. EMS was called when patient was about to pass out for a third time. EMS arrived and recommended patient be transported to hospital via ambulance. Patient refused to go and signed AMA waiver before leaving.
High fever, chills, severe muscle pain in injection site, inability to raise arm used for injection, fatigue, confusion, delayed and more severe menstrual period
Warmth, redness, itchiness, and swelling at injection site. Reaction area covering approx 3.5 inches in diameter on right arm. Recommended BENADRYL due to likely allergic reaction.
Fine rash noted face, arms, legs and abdomen. Rash was very itchy. No respiratory distress or swelling at injection site.
I started to experience pins and needles and tingling in both of my hands 5 days after my shot.  It went away for 2 days and then came back again.  When it came back, it was predominantly on the right side of my body.  It was no longer just in my hand though; this time it was also in my forearm, calf, and foot.   It?s now about 2 weeks later from when I first noticed the symptoms and it seems to be getting better.
Developed a localized red rash at injection site the size of the palm of my hand. Hard, red, itching. At the time of this report it was still hard, red with less itching. Since beginning I have been taking pepcid 20mg and 12.5mg benadryl daily and applying ice to site 2x daily.  No extreme allergic reactions i.e. SOB, lightheadedness.
Immediate armpit soreness lasting 5 days. Hives on face, arms, hands lasting 2 weeks. Hand and finger swelling. lasted 1 week.
Patient given PNEUMOVAX 23 on 11/1/2016. On 11/4/16 she presented to office with (L) upper arm redness, swelling, warmth to touch, and fever. Redness 11 cm x 11 cm.
nerve damage; permanent tremors; neurological injuries; painful shingles, lesions and blisters; Information has been received from a lawyer regarding a case in litigation concerning a male patient(pt) of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided. On 21-OCT-2014, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) at a pharmacy for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live(ZOSTAVAX), pt suffered debilitating injuries including painful shingles, lesions and blisters, nerve damage, permanent tremors and neurological injuries. These injuries were caused by zoster vaccine live(ZOSTAVAX). As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms have resulted in physical injuries and limitations not present prior to using zoster vaccine live(ZOSTAVAX) and caused by the zoster vaccine live(ZOSTAVAX). As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and disfiguring personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   The events painful shingles, lesions and blisters, nerve damage, permanent tremors and neurological injuries were considered as disability.
Patient received vaccine earlier than the 21 days. Patient was discharged following 15 minutes of observation after, stating that he is feeling well. Patient was later notified of the incident via phone on 06/16/2021 at  1440, and advised to contact EMS if he experiences any adverse reactions.
headache, sore throat, cough, chills, body aches, ear pain, sinus congestion, nasal congestion. starting on 10/23/21
Right sided facial swelling started 24 hours post injection.  No itching, pain or inflammation.  No tongue, throat or lip involvement
pt recv vax & devel n/v, diarrhea & cramping w/in 3 days of vax;this is 1 of 6 pt , out of 30 vaccinees, to exp rxn;
Onset of fever of 104 F approximately 1030PM. Developed nausea, no vomiting. Mother called PA at health center. Mom is to alternate MOTRIN and TYLENOL. Fever continued x 24 hours and gradually decreased to normal 98 range with alternating MOTRIN and TYLENOL.
20DEC90 "bad" swelling & redness lt leg; RN observed happy, smiling baby w/no systemic sx, afebrile, lt leg 1 1/2 size of rt leg, area of inflammation 5-6cm in dram adjacent to inject site on lt leg. Hot to touch & deeply erythematous.
influenza; tested positive for Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid-19) and INFLUENZA (influenza) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71418) for COVID-19 prophylaxis.    Co-suspect products included non-company products PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for an unknown indication and INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    The patient's past medical history included Prostate cancer in 2013 and Hernia repair on 09-Sep-2022. Concomitant products included LEUPRORELIN ACETATE (ELIGARD) for Cancer.   On 23-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Oct-2022, the patient received dose of PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (INFLUENZA) (unknown route) 1 dosage form. On 07-May-2023, the patient experienced COVID-19 (tested positive for Covid-19). On an unknown date, the patient experienced INFLUENZA (influenza). At the time of the report, COVID-19 (tested positive for Covid-19) and INFLUENZA (influenza) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2023, SARS-CoV-2 test: Positive.         No treatment information was reported.   This case was linked to MOD-2023-736316 (Patient Link).
pt recv vax 29AUG96 & 5OCT97 pt broke out w/less than 12 lesions on face, back, trunk & arms;MD noted that it looked like classic chickenpox;pt was just a little itchy;afeb & stable;
1/8 pain and palpable bump "malingering pain, constant burning sensation, point tenderness, red splotch on my arm 3in longx2in wide a bump(swelling) quite warm to touch and sometimes itchy"
First day had sore arm Second day-4th day after injection I could barely life my arm at all. After the first dose 7 days later I had a medical episode in my sleep that drs are trying to say was seziure.I have absolutely no family history of epilepsy,no major brain trauma in my life and was in perfect health prior to shot. Prior to the shot I didn't feel sick,I didn't have any kind of medical issues whatsoever.
Cough Diarrhea,  post-nasal drip,  fatigue,  decreased appetite,  chills Shortness of breath
shivers; fatigue; injection site warmth; injection site swelling; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of shivers in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a day after receiving Shingrix, the patient experienced shivers, fatigue, injection site swelling, injection site pain and injection site warmth. On an unknown date, the outcome of the shivers, fatigue, injection site swelling, injection site pain and injection site warmth were unknown.   It was unknown if the reporter considered the shivers, fatigue, injection site swelling, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient had swelling on the injection site for 2 days and asked about how can the swelling and pain go away. The patient also had fatigue and did not have shivers the first night. The patient asked if she could put ice pack at the injection site. The patient feels injection site warm to touch.
After getting the shot I experienced all the typical symptoms of a flu. Light headedness, soreness of my muscles, The shot location itself hurts very badly.  I do not believe it to be threatening to my long-term health in any manner but it does make me worry about taking the next dose that purportedly should be much worse.  I suffered chills the prior night and decided to file this report to help add to the information available.
Information was received from a nurse concerning a first grade student who on 12 MAR 2002 was vaccinated with a dose of Varicella.  During Christmas break 2004 the student developed chickenpox.  According to the school nurse there were 58 other elementary school students and 34 of them had previously been vaccinated with a dose of Varicella.  Unspecified medical attention was sought.  There was no information regarding the present status of the student.  No product quality complaint was involved.  Additional information was requested.
7 months pregnant at time of second dose and had normal pregnancy and delivery, with healthy 9lb 3oz and 21in baby at time of birth. Exclusively breastfed baby until 9/26/2021 when he died suddenly and unexpectedly. Cause of death has not been determined but in autopsy they did not find any indication of clotting or other issues; we are waiting on pathology and toxicology results.
Patient requested Shingrix, dose 1.  Immunizer incorrectly prepared Pfizer's COVID-19 vaccination, believing it was Dose 1  in the series.  Patient was given 0.25ml (87% of normal dose) before the error was discovered.   Patient has previously been vaccinated with Dose 1 and Dose 2 of COVID-19 with the Moderna vaccine, Dose 2 being given early February 2021.   Patient really wanted Dose 1 of Shingrix and chose to get the Shingrix in addition to the errant dose of COVID-19 that was given.
Information has been received from a physician concerning an 83 year old male with chronic obstructive pulmonary disease heart problems and no known drug allergies who on 28-JUL-2008 was vaccinated intramuscularly with the first 0.5 mL dose of PNEUMOVAX (LOT# 659487/1960U). Concomitant therapy included "pulmonary medication". On 29-JUL-2008 the patient experienced warmth, swelling and redness at the site of injection from shoulder to elbow of same arm after administration of his first dose of PNEUMOVAX vaccine. The patient was treated with MSD, TYLENOL, BENADRYL and KEFLEX. Subsequently, the patient recovered from the events. The patient sought medical attention in the office. This is one of several reports received from the same source. Additional information has been requested.
Patient is 17, therefore, not eligible for the Moderna vaccine, should have had the Pfizer as his booster. Moderna was inadvertanlty given per patient request. No adverse reaction was observed
Physician called on 08/01/2005 stated that patient was seen in office on 07/30/2005, came in with right upper arm swollen with clear liquid where vaccine was given.  Dr. stated that patient probably had a reaction from the vaccine given on 07/28/2005.
Patient got the shingles on Labor Day 2017 (September 4th, 2017).
LARGE RED SWOLLEN AREA WITH PAIN, WARM TO TOUCH THE DAY AFTER THE INJECTION.  CLIENT'S CAREGIVER REPORTED TO THE CLINIC. WAS INSTRUCTED TO USE ICE, BENADRYL, IBUPROFEN
Approximately 90 minutes following first dose of vaccine, developed severe headache, chills, joint pain and full body muscle aches. Continued throughout the night and were improved by next morning, but not fully resolved by the time of this submission.
Sore arm; chills; headache; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on 22Feb2021 11:00 as dose number unknown, single for covid-19 immunization. The patient pregnant at time of vaccination was unknown. The facility the most recent COVID-19 vaccine was administered was workplace clinic. The patient medical history and concomitant medications were not reported. On 22Feb2021, the patient experienced sore arm, chills, headache. the patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. The patient received any other medications within 2 weeks of vaccination was unknown. Prior to the vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received treatment for the events. The clinical outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
1/18/21 - headache and tiredness/ 1/19/21 - numbness in right arm, swelling in right hand/ 1/20/21 - loss of smell and taste - 1/23/21 returned for follow up at urgent care 1/28/21 - chest pain (Went to Ed for follow up) Covid test 0n 1/19/21, 1/21/21 and 1/23/21 (both a rapid and a send out test. All Covid tests were negative
On approximately 9/2/00, the pt received her third adult IM dose of Havrix. No treatment was given. As of 10/2/00, no adverse events were reported.
It didn't hurt going in, but after approximately 2 hours I felt pain in my left shoulder (like a tetanus shot). The next day I had extreme pain and some weakness. On day 3, the pain was minor. On day 4, it was gone.  I didn't have fever or any other symptoms except fatigue (but that could be because of Christmas!).
Intense muscle pain, fatigue, headache, nausea through the first night, swollen armpit the next morning, stabbing pain in abdomen and left breast the following morning, heart pain, rage, confusion next few days.
Vaccine injection site was sore for the first few days following vaccination. On 4/1/10, pt reported increasing discomfort, redness and hardness at the injection site.  Reported tender to touch.  Vaccine provider notified by phone 4/2/10. Recommended ice and call to MD. On 4/3/10, pt was prescribed cephalexin 500mg three times a day for 7 days.
Sore arm around the injection site; Rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm around the injection site) and VACCINATION SITE RASH (Rash around the injection site) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01020A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm around the injection site) and VACCINATION SITE RASH (Rash around the injection site). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore arm around the injection site) and VACCINATION SITE RASH (Rash around the injection site) had resolved. Not Provided          No relevant concomitant medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Outcome of the event was provided.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Patient experience emesis within 15 minutes of injection. Other sypmtoms were also felt at this time. Appeared to recover after receiving water.
pt exp gen erythema on chest area & behind both ears;no observable resp distress;pt appeared quiet & comfortable-immed escorted mom & pt to clinic;DPH given;mom remained in clinic 30min for observation;pt cont w/o any observable distress;
Child had 4hr period of lethargy/non responsiveness. No witnessed sz or apnea. Seen in ER - normal exam at that time - seen the next day - normal exam.
Inside is less red and the outside is more red; rash, large circle; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Inside is less red and the outside is more red) and RASH (rash, large circle) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ERYTHEMA (Inside is less red and the outside is more red) and RASH (rash, large circle). At the time of the report, ERYTHEMA (Inside is less red and the outside is more red) and RASH (rash, large circle) 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 con meds were provided.  Treatment details included None.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Breakthrough case admission after 5 vaccines Pfizer 3/2/21 Lot# EN6205;  Pfizer 3/23/21 LOt# EP6955;  Pfizer 9/29/21 LOt# FF2588;  Pfizer 6/10/22 LOt# FP7135;  Pfizer 10/14/22 Lot# GH9703
Varicella vaccine given 8-15-07 and 9-20-07. Client denies pregnancy at these dates. pregnancy test requested 9-28-07 and was negative. Client went to ER due to felt sick and tired and had a positive pregnancy test EDC 6-1-07
Chest pain; Dizzy; Spasm; Memory loss; Ringing ears; Off balance; Headache; Sleepy; A spontaneous report was received from a consumer who was also a 63-years-old, patient of unknown gender who received Moderna's COVID-19 Vaccine (mRNA-1273) and who felt dizzy/dizziness, off balance/balance disorder, sleepy/somnolence, memory loss/amnesia, chest pain/non-cardiac chest pain, headache, ears ringing/tinnitus and spasm/muscle spasms.   The patient's medical history included reflux, spasm and erosion gastritis. Concomitant product use was not provided by the reporter.   On 12 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient had chest pain, dizzy and spasm for which the patient had to take an ambulance to the hospital. No further details regarding hospitalization provided at time of report. The patient also had memory loss, ringing ears, sleepy, off balance and headache.  Treatment for the event included pepsid, doxycycline at 100 milligram 2 dose a day and baby aspirin.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested. The events were consistent with increased risk of complications associated with history of comorbidities and confounded by age of patient. Company assessed the events to be unlikely related to company product.