chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Nurse Practitioner referring to 3 unspecified patients of unknown age and gender. Information about the patients' concurrent condition, medical history, drug reactions/allergies and concomitant medication was unknown. On unknown dates, two patients were each vaccinated with a dose of improperly stored M-M-R II (dose and route were unknown, lot # L049455 with expiration date 03-DEC-2017) and additional one patient was vaccinated with a dose of improperly stored M-M-R II (dose and route were unknown, lot # M000768 with expiration date 05-JAN-2018). No adverse effect was reported. The vaccines had been exposed under temperature 48.9 Fahrenheit for 1 hour. There was no previous excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 2 year old male who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed a case of zoster. It was reported that the patient was hospitalized with a lesion on the foot. The outcome was not reported. He was noted to have a repeat incident at 4 years of age. No further details on the repeat incident were provided. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information was received from the physician who indicated that he could not remember the name of the patient. He noted that he will check within the hospital to determine the patient's name. Additional information has been requested. The physician also reported another child who had a case of zoster after therapy with varicella virus vaccine live (WAES0409USA01415).
Headache; chills/shivering; mild fever; muscle pain; pain/ itching/redness/swelling at injection site; diarrhea.   It felt like I was getting the flu, just like when I  had the first shot in March.
Herpes simplex 1 & 2; Anti Nuclear Antibodies; This case was reported by a consumer via call center representative and described the occurrence of herpes simplex in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 19th October 2018).   On 7th February 2019, the patient received the 2nd dose of Shingrix. In June 2019, less than a year after receiving Shingrix, the patient experienced herpes simplex and antinuclear antibody positive. On an unknown date, the outcome of the herpes simplex and antinuclear antibody positive were unknown.   It was unknown if the reporter considered the herpes simplex and antinuclear antibody positive to be related to Shingrix.  Additional details were provided as follows: The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient had done blood test last week from the date of reporting with positive result for anti nuclear antibodies and herpes simplex 1 and 2. The patient asked, if Shingrix causing a positive for these types of blood tests.      Lab Comments: IN 2019, the patient underwent blood tests for Anti Nuclear Antibodies and Herpes Simplex 1 & 2 and was positive for all tests.
Change in menstrual cycle (period came 5 days early and was substantially lighter); body aches; Headache; chills/rigors; painful swollen axillary lymphnodes in affected arm, still swollen 3 weeks later; painful swollen axillary lymphnodes in affected arm, still swollen 3 weeks later; abdominal cramping; lightheadedness; This is a spontaneous report from a contactable nurse (patient).  A 31-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK4176, expiry date unknown), via an unspecified route of administration on 08Jan2021 at a single dose as a Covid vaccine. Medical history included allergies to penicillin. Prior to the vaccination, the patient has not had COVID-19. There were no concomitant medications. The patient did not receive other vaccines in four weeks or other medications in two weeks. The patient received the first dose of BNT162B2 (lot number: EH9899) on 18Dec2021 at 11:00 AM on the left arm as a Covid vaccine. The patient has not been tested for COVID-19 post vaccination. The patient experienced headache, chills, rigors, body aches, abdominal cramping, lightheadedness, painful swollen axillary lymphnodes in affected arm, still swollen 3 weeks later on 08Jan2021 at 11:00 PM. The patient  also experienced a change in menstrual cycle (period came 5 days early and was substantially lighter) on an unspecified date in 2021. The patient did not receive treatment for the events. It was reported that the patient recovered from the events with lasting effects.
Nausea x 3 days blurred vision, dizziness, chest discomfort, high blood pressure - 4 hours Resolved without treatment
By patient's request both vaccines were given on left deltoid. After vaccines were given patient reported a fever of 101.5 F and felt better the day after without any treatment.
Mother called 6/1/10 reporting that childs hands were swollen. Hives, itching all over body and poss. fever. She reports onset as 5/30/10.
Localized erythema, tender to touch, warmth throughout, edema. Possible cellulitis.
Information has been received on 06/23/03 from a consumer concerning his 4 year old daughter with no known allergies who "2 weeks ago" was vaccinated with varicella virus vaccine live (site unknown). There was no concomitant medication. Subsequently, the pt developed a sore throat, runny nose and had "about 5 lesions that look like chickenpox." The pt sought unspecified medical attention. There were no lab tests performed. Additional information has been requested.
Low grade fever. Left arm had red/purple mark that went from mid upper arm to shoulder. Hot to touch and swollen.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EN9581), in right arm, on 06Mar2021 as dose 2, single (Lot number: EN6200), in right arm, on 26Sep2021 as dose 3 (booster), single (Lot number: 301308A), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pre-diabetes" (unspecified if ongoing), notes: pre-diabetes; "High blood pressure" (unspecified if ongoing), notes: high blood pressure; "Heart palpitations" (unspecified if ongoing), notes: heart palpitations; "Hyperthyroidism" (unspecified if ongoing); "Known allergies: Kiwi" (unspecified if ongoing), notes: known allergies: Kiwi. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Negative; (Aug2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical information: Covid 19 Treatment (Paxlovid) was started at 31Jul2022 and stopped at 04Aug2022 with indication of Treatment of COVID-19.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improper stored VARIVAX (lot# N034559, expiration date: 05-DEC-2019, strength, dose, frequency and route were unknown) for prophylaxis reconstituted with well stored sterile diluent (Product storage error). The vaccines had temperature excursion of 15 degree F to 46 degree F (18.9F) for 7 hours 18 minutes. Previous temperature excursion was 15 degree F to 46 degree F (14.5 F) for 48 minutes. The call was due to the digital data logger. No adverse event was reported. This is one of several reports received from the same reporter.
I received my first COVID 19 vaccine on March 02, 2021 with relatively mild symptoms, including headache, fatigue and soreness at the site of the shot. I received my second Covid 19 Vaccine on March 23, 2021, again with the same relatively mild symptoms lasting only a few days. In the first week of April after receiving both vaccinations I started having some more serious side affects, which in the beginning I didn't know if it was related to the vaccine or not.  My side affects included serious nausea throughout the day, vomiting at times, a lack of  appetite throughout the day, fatigue, and headaches daily and no warning when these would occur. I also started having serious food aversions both with taste and smell. These side affects continued throughout the summer, some days worse and others not as bad.Late in the Fall my side affects started to decrease in severity somewhat. I had my annual physical in November with my internist and she told me to take 2 omeprozole instead of one, which I did. It didn't help at all. In December I started thinking about  whether or not I was going to get the COVID 19 Booster because we were traveling in January 2022. We wanted to be as protected as possible so we wouldn't get sick. I decided to get the booster on January 8, 2022. I had mild side affects similar to what I had with the first 2 shots. About 6 or 7 days later the side affects returned full force, just as bad as they were when it began in April 2021. This is when I realized that these side affects were caused by the vaccine. I was then 100% positive of this. My trip was not the most pleasant because of the nausea, lack of appetite, and headaches.I  lost 20 lbs from April 2021 to July 2021 because of these side affects and it wasn't a pleasant way to do that. My life has been significantly impacted in a negative way. It's even difficult to work or do my daily activities without challenges. I have never had COVOD at least to my knowledge and am wondering if I have a natural immunity. I would appreciate any assistance with these issues. Thank you. I have been told I may be a long hauler with the vaccine.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. It was reported that an unspecified number of unspecified patients received an unspecified number of improperly stored doses of GARDASIL (intramuscularly, dose, frequency and lot # not reported) since an unspecified date in December 2014. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
shrill crying-inconsolable x 3 hrs p/DTP vax given @ 1230PM; crying from 2PM-5PM;
Sick; Initial information was received on 01-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (demographics unknown) who had sick (illness) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Every year that I have gotten the flu shot I was in bed for over 10 days. Every year that I didn't get the flu shot I wasn't sick at all. So no more flu shots and I haven't been sick since"  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
A report has been received from a health professional, concerning a patient of unknown gender. No concomitant medication or relevant history was provided. The patient received FLUMIST Quadrivalent (intranasal), 0.2 milliliters with unknown frequency. It was administered in single nostril. The outcome of the event of FLUMIST was administered in single nostril was unknown. The report was considered to be non-serious by a company physician.
Dizziness, Asthma, Fatigue, Shortness of breath, when walking or climbing stairs.
A fever on the spot; Red spot came up with just a little rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red spot came up with just a little rash) and FEELING HOT (A fever on the spot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced RASH ERYTHEMATOUS (Red spot came up with just a little rash) and FEELING HOT (A fever on the spot). At the time of the report, RASH ERYTHEMATOUS (Red spot came up with just a little rash) and FEELING HOT (A fever on the spot) 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.   Concomitant medication were not provided by the reporter. No treatment information were given by the reporter. Next vaccine scheduled on 11 March was noted.
Feels weak; Hearing problem; Appetite problems; Trouble sleeping at night; Issues communicating; Not able to process things; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Feels weak), HYPOACUSIS (Hearing problem), APPETITE DISORDER (Appetite problems), INSOMNIA (Trouble sleeping at night) and COMMUNICATION DISORDER (Issues communicating) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Feels weak), HYPOACUSIS (Hearing problem), APPETITE DISORDER (Appetite problems), INSOMNIA (Trouble sleeping at night), COMMUNICATION DISORDER (Issues communicating) and DISORIENTATION (Not able to process things). At the time of the report, ASTHENIA (Feels weak), HYPOACUSIS (Hearing problem), APPETITE DISORDER (Appetite problems), INSOMNIA (Trouble sleeping at night), COMMUNICATION DISORDER (Issues communicating) and DISORIENTATION (Not able to process things) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported No treatment medication was reported
HERPES OUTBREAK; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received guselkumab (solution for injection, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication.  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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced herpes outbreak. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable; and action taken with guselkumab was not reported. The outcome of herpes outbreak was not reported. This report was non-serious. This report was associated with product quality complaint 90000188238. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as reported complaints were adverse events) based on the PQC evaluation/investigation performed. Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sore Arm, Nausea, Chills, Body Ache, Headache - All lasting through the night, treated with over the counter pain relief (Ibuprofen & Acetaminophen)
This case was reported by a consumer and described the occurrence of calf twitches in a 31-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 9 November 2010 at 14:00 the subject received unspecified dose of ENGERIX B  (unknown, left arm). On 16 November 2010, 7 days after vaccination with ENGERIX B, the subject experienced twitching in calf and numbness in left hand. At the time of reporting the calf twitches and numbness in hand were unresolved.
Patient arrived for her appointment around 1:05 pm. She received the vaccine after reviewing the pre-vaccination questions. She received her vaccination without incident around 1:10pm and waited in her car for the prescribed 15 minutes. Around 1:20, she honked her horn, indicating she was experiencing something not normal. Nurse responded immediately. When nurse got to the car, patient appeared anxious and diaphoretic. Nurse took her BP and pulse. Her first reading was 160/104 with a heart rate of 104. Client was now calm and had caught her breath by 1:22pm. Patient said she had this happen before when she was pregnant years ago. She said she was light-headed and had tingling feet. Patient stated she had not taken medication and had no known medical conditions. Her BP was taken again at 1:25, and it was 158/92 with a heart rate of 72. The nurse monitored these tests again at 1:30, and the BP went to 144/84 and heart rate was still 72. Client said she was able to drive and return to work. She said she worked 10 minutes away. Our nurse recommended she call work to tell them she was coming. The client was no longer in any distress according to our nurses observation.
Received the Flu shot, and the Meningococcal B Vaccine at the same time and a few hours later came down with chills, hot flashes, and body aches. The same thing happened last year when she received the Flu shot.
High fever (101.5), head ache, chills, body aches, fatigue, diarrhea,
About two hours following vaccination I had an apparent panic attack with confusion, agitation, and a tremendous feeling of discomfort. I had a horrible exacerbation of hemoroids and the effects of my diuretic were enhanced a great deal. This lasted about 6-7 hours.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 28-AUG-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Really hard; Bodyache; Chills; Headaches; Really swollen today/Has been swollen/Swelling; Really tired/Tired; Heart palpitations; site of the shot got hot last night; premature ventricular contractions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (site of the shot got hot last night), VENTRICULAR EXTRASYSTOLES (premature ventricular contractions), MUSCLE RIGIDITY (Really hard), PALPITATIONS (Heart palpitations) and MYALGIA (Bodyache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Stent placement and Premature ventricular contractions. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.   On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced VENTRICULAR EXTRASYSTOLES (premature ventricular contractions). On 25-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE WARMTH (site of the shot got hot last night), PALPITATIONS (Heart palpitations) and FATIGUE (Really tired/Tired). On 26-Sep-2021, the patient experienced VACCINATION SITE SWELLING (Really swollen today/Has been swollen/Swelling). On 27-Sep-2021, the patient experienced MUSCLE RIGIDITY (Really hard), CHILLS (Chills) and HEADACHE (Headaches). 27-Sep-2021, the patient experienced MYALGIA (Bodyache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (site of the shot got hot last night), MUSCLE RIGIDITY (Really hard), PALPITATIONS (Heart palpitations), MYALGIA (Bodyache), FATIGUE (Really tired/Tired), CHILLS (Chills) and HEADACHE (Headaches) outcome was unknown, VENTRICULAR EXTRASYSTOLES (premature ventricular contractions) had resolved and VACCINATION SITE SWELLING (Really swollen today/Has been swollen/Swelling) had not resolved.            Tylenol was given as treatment medication for adverse event.   This case was linked to MOD-2021-333788 (Patient Link).; Sender's Comments: This case concerns a 61-year-old, female patient with relevant medical history of Premature ventricular contractions, who experienced the unexpected non serious events of vaccination site warmth, swelling, palpitations, pain in extremity, premature ventricular contractions and condition aggravated and expected events of fatigue, chills, headache, vaccination site swelling and myalgia. The events occurred approximately 1  to 2 days after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided.  The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient's pertinent medical history and concomitant medications were not reported. On 23-APR-2015, the patient was vaccinated with an improperly stored doses of GARDASIL (dose and route were not reported; lot ;# K006191, expiration date 02-FEB-2017). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Janssen vial diluted and given to patient.  Vial mix up. vial was mistaken to be Pfizer by tech
03/11/2021 in the morning the injection site was so painful I couldn't put pressure, fatigue, chills, digestive symptoms vomiting, for 2 weeks. Every couple of days it would come back. My doctor told me to take Tylenol but it didn't help much.
pt recvd vax & 2-3 days a/development of sx & findings of GBS sx progressed resulting in resp failure requiring ongoing mech ventilation;