chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She developed a "hard ball" at the injection site; He states the area is slightly warm to the touch; Slightly red; Slightly raised; When you press on the side of the injection, it feels like a bruise; This spontaneous report was received from a pharmacist concerning to an approximately 20-year-old female patient. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On 22-JUL-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscularly on her left deltoid (strength, dose, lot # and expiration date were not provided) for prophylaxis.         On the same date (reported as "after receiving the vaccine injection"), the patient developed a "hard ball" at the injection site (injection site induration). Moreover, the pharmacist also reported that the patient stated that, since an unknown date in 2020, the area was slightly warm to the touch (injection site warmth), slightly red (injection site erythema) and slightly raised (injection site mass). Furthermore, she stated that "when she pressed on the side of the injection, it felt like a bruise (contusion). The patient did not seek for medical attention. At the time of this report, the hard ball was still present; however, no abscess was noted in the area. The outcome of the events of injection site induration, contusion, injection site mass, injection site erythema and injection site warmth was reported as recovering.   The causality assessment between the reported adverse events and vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Information has been received from a nurse practitioner concerning a 64 year old male with hypercholesterolaemia and chronic gingivitis and no allergies who on 19-JUN-2008 was vaccinated with ZOSTAVAX "1 vial" SC (lot #659760/0159X). Concomitant therapy included LIPITOR and doxycycline. On approximately 26-JUN-2008, one week after vaccination, the patient experienced optic neuropathy. The patient lost some of his vision. The patient was seeing an ophthalmologist. The patient's optic neuropathy was recovering. The patient's optic neuropathy was considered to be disabling. Additional information has been requested.
Severe numbness in hands and feet upon waking, by 11am numbness progressed to knees, went to family physician who admitted me to hospital, diagnosed with GBS, 2 lumbar punctures, EMG, and IVIG given during 2nd hospital admission.
This spontaneous report as received from a medical assistant refers to patients of unknown demographics. On unknown dates the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # M013377, expiry date 25-MAY-2017). The temperature and timeframe that the ZOSTAVAX was exposed to were as follows, Temperature: 14.9F, Time frame: 1 hour. There were no previous temperature excursions. Data Logger was involved. The medical assistant confirmed that the improperly stored vaccines were administered. No adverse effect was reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
this baby was scheduled for a 6 month Well visit  10 days too soon (10 days before actually turning 6 months). The nurse administering the vaccine did not notice that the patient was not quite 6 months yet as the Intake form was marked "6 months". This situation was not discovered until the patient returned to the office 2 months and 4 days later to receive the second dose. Mom was informed of the mistake and reported that baby had no side effects from Dose 1. The patient's doctor  was informed of the situation.
Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an elderly patient who developed secretions in his throat, while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine lot number not reported. On an unknown date, the patient developed a non-serious secretions in his throat (Increased upper airway secretion) following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. No lab data reported. Final diagnosis was secretions in his throat. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for secretions in his throat.
Patient fell asleep outside without shirt on. Sustained second degree sunburn to over 50% of left arm. Patient was 11 days post smallpox administration into deltoid of limb. Also exhibited numerous sites of white pustules to lower limb beginning at elbow and extending distally over medial lateral aspect of same appeared intact with moderate amount of pus in each. No sites like this above elbow.
Swelling and redness that has evolved into a shallow ulcer that won't heal.  Patient hasn't sought attention until 6/22/10.
Patient called me on the morning of 10/20/2007 to report that her left deltiod was inflamed, red, hot and sore. This occurred late last night and had not progressed since then. Area affected was about palm-sized around the area where the shot was administered and was localized. She felt fine otherwise and didn't have any chest tightness, hives or breathing problems. I instructed her to take benadryl as directed on the box, ibuprofen, and to ice the area periodically throught the day. I will follow up tomorrow morning.
Large R pleural effusion; Worsening shortness of breath; cough; This spontaneous case was reported by an other health care professional and describes the occurrence of PLEURAL EFFUSION (Large R pleural effusion) and DYSPNOEA (Worsening shortness of breath) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lung cancer in 2007, Restless leg syndrome, Tobacco user, Neuropathy, Hyperlipidemia and Radiation therapy in 2010. Concurrent medical conditions included Hypertension and Type 2 diabetes mellitus (TYPE 2). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), GABAPENTIN, IRBESARTAN, ROPINIROLE, INSULIN GLARGINE (LANTUS), METOPROLOL and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced PLEURAL EFFUSION (Large R pleural effusion) (seriousness criterion hospitalization), DYSPNOEA (Worsening shortness of breath) (seriousness criterion medically significant) and COUGH (cough). The patient was hospitalized for 1 day due to PLEURAL EFFUSION. At the time of the report, PLEURAL EFFUSION (Large R pleural effusion), DYSPNOEA (Worsening shortness of breath) and COUGH (cough) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: Confluent right hilar lymphadenopathy and a large effusion was seen. On an unknown date, Computerised tomogram thorax: abnormal (abnormal) abnormal. On an unknown date, Full blood count normal: normal (normal) normal. On an unknown date, Metabolic function test normal: normal (normal) normal. On an unknown date, SARS-CoV-2 test: negative (Negative) NEGATIVE.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Cytology was significant for reactive mesothelial cells and negative for any malignancy. confluent right hilar lymphadenopathy and a large effusion was seen.  Company Comment: 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.   This case was linked to MOD-2021-162944 (Patient Link).; 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.
Pt. received  Moderna (1st dose) on 04/22/2021 and Pfizer (2nd dose ) on 05/19/2021.   No adverse reactions observed.
Patient was given the Varicella vaccine in right lower vastus lateralis subq. within 1-2 mins. after injection, complained of itch, red rash noted around injection site, given liquid BENADRYL for treatment.
Pt recvd 2 booster doses of Engerix-B 10FEB92 & 9MAR92; p/recvd 2nd dose felt faint & nauseated, awoke 10MAR92 w/itchy rash all over body; took DPH; also exp lightheaded, broke out rash, hives, itching;
Patient was hospitalized 3 times within  6 weeks of receiving COVID vaccination for mitral valve regurgitation, nonrheumatic mitral insufficiency, and mitral valve repair. DOS 4/27/21, 5/4/21, 5/17/21.
No adverse event; Expired Moderna vaccine given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine given) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Sep-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 17-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine given). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine given) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine given).    No concomitant medications were provided. The nurse practitioner stated that expired Moderna vaccine was given.  The dose on the vial was 100 mcg/0.5 ml, but the vial volume was unknown.  The patient information was unknown, but it was the second dose for the patient. The nurse practitioner did not have the date of initial thaw.  The date of vial which was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. No treatment medication was provided.
Patient left the pharmacy area and when to check out his groceries. While in line, the patient became dizzy and started sweating profusely. The cashier got him a chair so he could sit down. She gave him a cold water and some candy. I came over and asked him about low blood sugar and if he had eaten since I knew he was a diabetic. He sat in the chair for about 20 to 25 minutes. after he drank the water and ate the candy, i did a blood pressure reading, a temperature reading, and a blood glucose reading.  The patient was able to leave and drive home after eating the candy and drinking the water.
Patient experienced vasovagal syncope approximately 5 minutes after vaccination. Patient regained consciousness shortly after. He was monitored by EMS in the pharmacy and left shortly after and was feeling fine.  The patient's mother spoke with us a few hours later when she was separately at the pharmacy and stated he was feeling fine and had no further issues.
grandma called stated that pt has a red raised area where got shot & has a fever;has not taken temp & has been screaming for 30mins;APAP had been given;advised to contact mom & notify childs MD or take to ER if unable to contact PMD:
This case was reported by a nurse and described the occurrence of injection site burning in a female patient who received hepatitis B vaccine recombinant (Engerix B). On 11/19/2004, the patient received the 1st dose of Engerix B in the left arm (lot ENG5595BC incorrect lot number). At an unspecified time following the first administration of Engerix B, on 11/19/2004, the patient experienced an injection site reaction characterized as burning. The events resolved on 11/19/2004. The nurse reported that,, the vaccine had just been removed from the refrigerator prior to the injection and it was cold. the nurse considered the injection site reaction to probably be related to vaccination with Engerix B.
Chest burning and tightness and SOB. Gave albuterol neb and Benadryl.
got vaccine while being pregnant; A spontaneous report was received from a health care professional who was a 35-year-old female patient who received Moderna's COVID-19 vaccine and she was 11 weeks pregnant.   Patient's medical history included congenital heart disease in 2014 and supraventricular tachycardia in 2018 and a surgery was done in 2018 and concomitant medicines reported as taken by the patient included prenatal vitamins, baby aspirin, metoprolol, Dexilant, Pepcid.        The pregnancy history of the patient included 3 prior pregnancy history with 2 live, full term birth on 11-FEB-2016 and 25-AUG-2017   and one spontaneous abortion on 22-SEP-2020.  On 14 JAN 2021, the patient received the first of two planned doses of mRNA-1273 intramuscularly in the left deltoid (non-dominant arm) for prophylaxis of COVID-19 infection. On 14 NOV 2020, the patient had a positive pregnancy test. The first day of the patient's last menstrual period was on 23 OCT 2020. The estimated date of conception was unknown, and the due date was estimated as 31 JUL 2021. The patient has prior history of use of alcohol and was allergic to Amoxicillan and levoquin  The laboratory investigations include ultrasound and genetic testing on 14-JAN-2021, the reports were unknown. Action taken with mRNA-1273 was not reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
My first period after the vaccine was abnormal for me.; There was no blood; 24 days I have had bleeding ranging from black to bright red/My cycle is normally very regular; This is a spontaneous report from a contactable Nurse (Patient). A 22-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FA6780), via an unspecified route of administration on 02Jul2021(at the age of 22-years-old) administered in Arm Left as a single dose for COVID-19 immunization at Pharmacy or Drug Store. Medical history included ehlers-danlos syndrome, covid-19 (all from an unknown date and unknown if ongoing). Concomitant medication(s) included omeprazole; montelukast; Multivitamin (all taken for an unspecified indication, start and stop date were not reported). The patient did not receive any other vaccine in four weeks. The patient had no allergy. On 20Aug2021, it was reported that the patient first period after the vaccine was abnormal. There was no blood, only lining shed. She had four days after that with nothing. And now for 24 days She have had bleeding ranging from black to bright red. Her cycle was normally very regular. No treatment was given for the events. Post vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  Follow-Up (28Sep2021): Follow-up attempts are completed. No further information is expected.
Myalgia, Arthralgia, Fever, Diarrhea, chills, fever, BA,diarrhea x1, HA. Took Tylenol/Ibuprofen. Narrative:
redness, rashes and hives on both arms, thighs and up my right side of the torso
anaphylaxis reaction, received Prednisone and Benedryl through an IV drip, as well as an epipen at Hospital. Full body hives continued to appear for 2 days. Friday, November 12 was the first day that no additional hives appeared. I am still taking Prednisone, Pepcid, and Benedryl. I was also sent home with an epipen and need to see an allergist.
I got my shot on a Friday afternoon. The following Tuesday afternoon, I was out running sprints with a friend. After a couple, I felt super winded, like I was gonna pass out. This was concerning since I run at least 30 miles a week.   Early the next morning, I woke up with my heart racing and shortness of breath. This persisted for a couple of hours. I woke up with a stiff chest, pain and aches around my body, and struggling to breathe. I went to urgent care and they did an EKG on me that came out abnormal. They referred me to a cardiologist where I got an appointment the next day.   The cardiologist runs another ekg this time it?s worse. She sends me straight to the ER. They run a bunch of tests but nothing is conclusive. I?m released the next evening.   The following Monday I had a checkup with my cardiologist and she referred me to someone she knows at a HCF. My appointment is not until the end of June
nausea, malaise, chills, fever.  Tylenol and Benadryl
Information has been received from a health professional through the Merck pregnancy registry concerning a 17 year old female with no known medical history or allergies who on 08-SEP-2005 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot # 648943/0893P). Concomitant vaccination that day included hepatitis B vaccine, recomb (MSD). Concomitant therapy included amoxicillin (AMOXIL). On 28-SEP-2005 the patient reported being pregnancy with an LMP of 22-AUG-2005. No adverse experiences were reported. Unspecified medical attention was sought. No laboratory diagnostic tests were performed. There was no product quality complaint involved. Follow-up information from health professional indicated that as of February 2006 there were no adverse experiences to either the mother or the fetus. Information regarding the birth of the patient's child was not available. Additional follow-up information indicated that the patient  was seen in the office on 22-FEB-2006, then the patient was transferred to a different office due to a "high risk pregnancy". Additional follow-up information indicated that the patient was transferred to a high risk practice at 33 weeks due to pre-term labor. On 29-APR-2007, at 35.5 weeks gestation, the patient delivered a baby girl. The apgars were reported to be 4 and 8. It was reported that the baby was transferred to the NICU for further care.
Itchy; Redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) and ERYTHEMA (Redness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced PRURITUS (Itchy) and ERYTHEMA (Redness). At the time of the report, PRURITUS (Itchy) and ERYTHEMA (Redness) outcome was unknown. Not Provided          No Concomitant medications were provided No Treatment information provided
Myalgia, Fever, NauseaVomiting, HEADACHE, FATIGUE Narrative:
Scabbed for a month that was itchy. Felt burning sensation right below where vaccinated then moved to elbow to lower arm. Still hurts right below shoulder, very painful @ elbow. Still feel a burning sensation and shoulder hurts.
pt recv vax 15MAR95 & several hr p/vax pt devel swelling, pruritus & erythema in lt arm @ the inj site;ice packs applied;marked swelling & erythema persisted for approx 10 days, gradually subsided, & then cleared;
pt recvd vax & 3 days later started to have some trembling; 6 days later exp szs & was taken to hosp; the following day pt stopped breathing; adm to hosp;
the patient does not have any titers for the measles virus; This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. The patient's pertinent medical history, allergies and concomitant drugs were unknown by the reporter. The patient's concurrent conditions were not provided.  On an unknown date, the patient was vaccinated as a child with unspecified Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) for prophylaxis (also reported as childhood vaccination) (dose, strength, frequency, route of administration, lot number and expiration date were not reported).   On an unknown date, the patient does not have any titers for the measles virus (Measles antibody negative). No medical attention was sought. The patient's wife was in her first trimester and was not sure that what her titer was for measles but did had an unspecified measles vaccine given on an unspecified date when she was a child.  The outcome of the event measles antibody negative and the causal relationship between the event and the vaccine Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) was not reported.
Pt recvd pneumococcal vax & devel a local rxn which consisted of cellulitis & swelling of the entire arm; pt recvd inject of cortisone & w/in 3 to 4 days the sx subsided; no further details were provided;
Symptoms occured after both first dose (Aug 21) and second dose (Sept ).  Intermittent episodes of chest and upper back pain sometimes accompanied by shortness of breath, dizziness and nausea, beginning 3 days after the first dose and resolved after about day 5.  With second dose symptoms began the next day and escalated over several days, still ongoing now (7 days later) but some improvement compared to 2 days ago. Symptoms usually occurred with light exertion (attempting usual activities which normally do not cause these symptoms).
pt recvd vax 19JUL95 & 21JUL states pt w/swelling @ DTAP inj site; evaluated in clinic by practioners on 21JUL95; no fever, no irritabilityy, good ROM lt arm; on exam, lt upper arm warm to touch;
feverish; shaking so bad he couldn't stop; had pain from the bottom of elbow to the bottom of the neck; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feverish), TREMOR (shaking so bad he couldn't stop) and PAIN IN EXTREMITY (had pain from the bottom of elbow to the bottom of the neck) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (feverish), TREMOR (shaking so bad he couldn't stop) and PAIN IN EXTREMITY (had pain from the bottom of elbow to the bottom of the neck). On 02-Apr-2021, PYREXIA (feverish), TREMOR (shaking so bad he couldn't stop) and PAIN IN EXTREMITY (had pain from the bottom of elbow to the bottom of the neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up re received on 16-JUN-2021 and it contains No new information.
On 12/23 reports feeling fatigued all day. At approximately 4:30 pm on 12/23 began having fever (100.4), body aches, and headache. These symptoms subsided at approximately 11:00 pm on 12/23. On 12/24 had no symptoms and felt fine.