chrisvoncsefalvay/vaers-outcomes huggingface dataset:
One patient recieved a vaccine, three days after the expiration date of 30Sep2022; Upset stomach; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  An 8-year-old male patient received BNT162b2 (BNT162B2), on 03Oct2022 as dose 3 (orange cap; booster), single (Lot number: FL2757, Expiration Date: 30Sep2022) at the age of 8 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Vaccine Name: First Pfizer Covid vaccine, Lot Number/Expiry Date: FL0007/ 28Jan2022, Anatomical Location: not provided), administration date: 02Dec2021, when the patient was 7-year-old, for COVID-19 immunization; BNT162b2 (Vaccine Name: Second Pfizer Covid vaccine, Lot Number/Expiry Date: FL0007/ unknown, Anatomical Location: not provided), administration date: 03Jan2022, when the patient was 7-year-old, for COVID-19 immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 03Oct2022, outcome "unknown", described as "One patient recieved a vaccine, three days after the expiration date of 30Sep2022"; ABDOMINAL DISCOMFORT (non-serious) with onset Oct2022, outcome "unknown", described as "Upset stomach". Therapeutic measures were taken as a result of abdominal discomfort.  Additional information: When they calculated the 10-week expiry date in the refrigerator, this was 27Oct2022. However, the expiry date according to the manufacture date was 30Sep2022. A dose of this vaccine was administered to a patient 3 days after 30Sep2022. She spoke with patient, and everything was alright except, the patient had an upset stomach. The patient's doctor told the patient to take an over-the-counter stomach medication: Reporter states patient did not specify name of medication, or if the medication had been taken at the time of the phone call. Upset stomach: past couple of days, between the dates of 07Oct2022 and 11Oct2022. Reporter states it was unknown if the stomach upset, was continuing. Reporter seriousness for One patient received a vaccine, three days after the expiration date of 30Sep2022 and stomach upset: Not Serious. Patient did not visited to emergency Room and physician Office. Patient had no prior Vaccinations (within 4 weeks).
1 of 3 pts who exp a local reaction; pt had tenderness, mild swelling & redness @ site; ice applied to site; recovered;
Felt feverish on 10/22.  On 10/23 Noticed at 08:00 AM itching on back and neck.  Developed widespread pruritic urticaria on trunk, legs and neck.
(Lot# 040B21A, Exp. 10/02/2021). I never had tingling or tinnitus. Within 15 minutes from the injection, pain at the right arm and neck, and tingling at the right pinky (hand). Within 1 hour from the injection, nausea. Within 5 hours from the injection, tingling at the right arm, which then extended to the right side of my back, and also to the bottom of my right foot. During the night, muscular spasms (arms, legs), and heart palpitation. During the following 2-3 days, pain at the right side (arm, neck), tingling, pain in the right ear, a few spasms over my right eyebrow. External side of right arm felt colder, and slight loss of sensitivity at right pinky. During the three nights following vaccination, 'trigger finger' (right pinky), and some jerky movements (foot, legs). Tinnitus came within 8-10 days from vaccination, but today (24 days after vaccine) is gone. Symptoms gradually subsided but tingling came back after a week (after 15 minutes of mild jogging), and again after playing tennis (19 days after vaccination), and involved the right pinky (arm), right pinky (foot), bottom of foot. Now I am alright.
PT WAS GIVEN HPV IN L-ARM ON 8/12/2008 PT THEN RETURNED TO OUR OFFICE ON 8/13/2008 C/O BEING DIZZY, VOMITING, HEADACHE, AND DIARRHEA. C/O FEELING TIRED SINCE THE SHOT. ADVISED PT TO MODIFY DIET AS TOLERATED AND TO CALL IF PT STARTS HAVING SEIZURES OR SEVERE WEAKNESS
Headache, Diarrhea, NauseaVomiting, Fatigue Narrative: Patient started experiencing adverse events (soreness, diarrhea, nausea, fatigue, headache) day after receiving vaccine
Sore arm beginning 2 hours after injection, lasting 3 days.  Headache beginning 5 hours after injection, lasting 12 hours.
Office visit note from 12/10/2019 Subjective data: On December 1, 4 days after receiving the Shingrix vaccine, patient developed itchy hives over her torso.  Both sides of her body.  No scabbing. Then a full week later, patient developed hives near her axilla bilaterally. Patient cannot think of any other new things in her life, no new medications, shampoos, body wash, lotions, clothes, etc Pruritus is keeping her awake at night  Care Plan/Assessment:
This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported age: 78; Units: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10 Feb 2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On unknown date in 2021 she gets nervous. Patient stated she received the first shot of the Pfizer covid vaccine and her appointment is on 03 Mar 2021, but the card does not tell her what time she needs to be there by. Outcome of the event was unknown. Follow-up attempts are completed; information about lot number/batch number cannot be obtained.
Following immunization patient's left upper arm/deltoid was sore and she noted decreased ROM with abduction, flexion and internal rotation reaching behind her back. Patient was given vaccination 8/4/06 and has had no improvement or change.
Accompanied by mom. Patient crying and needed comfort throughout getting covid vaccine. Vaccine administered and still crying throughout 15 minute waiting period. Patient started complaining about throat pain and vital signs taken. Vital signs: 126/65 HR: 71 Resp: 22 and 02: 96. 02 stayed above 96. Patient crying throughout and breathing heavily. Medical alert response called and RN and MD  came to assess patient. MD stayed and assessed patient. MD advised to have patient wait outside away from vaccination area and will come back to assess again. Patient waited outside with RN and MD assessed and cleared patient to go home.
Pt recvd vax 3SEP92 exp fatigue, arthralgia, myalgia, transient nausea & diarrhea; pt seen by MD & prescribed ATB & anti-diarrhea medication 4-6 wks p/sx; recvd 2nd inject w/no react;
On Friday 3/19/2021 I woke with my head hurting & a low fever. My head hurt  for 3 days also the fever lasted for 3 days.I took tylenol of these symptoms. On Friday night I noticed a red patch on my right arm just below the shot sight. I put alcohol on the area and it is still their. On Sunday the 21st the site was still red but started to itch and it has a rash on it. The site area  to the present is still red has a rash and itches.I had a doctors appoint on Thursday the 25th for something unrelated so I did tell my primary doctor.
delayed cutaneous hypersensitivity reaction  Narrative:  self resolved. Symptoms 1 week post injection. itchy, warm, sore, size of mosquito bite, indurated. Treated with self care-ice pack, acetaminophen, diphenydramine, cortisone cream
Severe pain and discomfort in the testicle region for up to 24 hours.
Itchy red blotches on arms, legs and torso especially around the injection site. Fever of 102.7, took one Claritin and put hydrocortizone cream on the spots.
Information has been received from a physician and the Clinical operations manager concerning a 4 month old female who on 03-SEP-2008 (also reported as 04-SEP-2008) was vaccinated with PNEUMOVAX (lot # not reported) instead of (PREVNAR), (human error). The clinical operations manager said the human error was that the labels of the vaccines had the same color and the nurse accidentally grabbed the wrong vial. The clinical manager indicated that the practice has instituted changes to prevent such errors from occurring again. they are using caution stickers on the units which will remind the nurses to select the correct vial. The practice also is using separate shelves to separate adult doses from pediatric doses. No adverse effects reported. Additional information has been requested.
Tested positive for covid/covid in nasal passages; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive for covid/covid in nasal passages) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 027L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ATENOLOL for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for covid/covid in nasal passages). At the time of the report, COVID-19 (Tested positive for covid/covid in nasal passages) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab data include took BP and O2 saturation daily and were with in normal limits. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow up received on 18 Jul 2021 and updated lab data in i narrative.
Client returned to clinic on 12/6/12 at 2pm c/o hives and intense itching. Client noted to have 2 large areas to upper posterior arm. No heat present to palpation. Client stated spots were present upon waking this AM and are slightly painful to touch. Client also has rash appearing on bilat arms, waistline, back, and legs with tracks present.
Approximately 20 minutes after vaccination patient c/o feeling lightheaded, hands tingling and feeling as if there was something in her throat.
Patient was aged  13 at time of vaccination and received 5-11 year old formulation
Noted itchy rash and skin sensitivity to back side of abdominal region on day 10  post vaccination
a number of pt recv vax & had more MMR rxn than usual;the reporter indicated that all of the pt were fine;
stroke; Completely lost vision in right eye which came back; migraine; fatigued kicked in, very tired,exhausted; nauseated; throwing up; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) and BLINDNESS TRANSIENT (Completely lost vision in right eye which came back) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Stroke. Concomitant products included METFORMIN, LISINOPRIL, GLIMEPIRIDE, ROSUVASTATIN CALCIUM (CRESTOR), PIOGLITAZONE HYDROCHLORIDE (ACTOS) and CANAGLIFLOZIN (INVOKANA [CANAGLIFLOZIN]) for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced MIGRAINE (migraine), FATIGUE (fatigued kicked in, very tired,exhausted), NAUSEA (nauseated) and VOMITING (throwing up). On 06-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion hospitalization) and BLINDNESS TRANSIENT (Completely lost vision in right eye which came back) (seriousness criterion medically significant). The patient was hospitalized from 06-Apr-2021 to 09-Apr-2021 due to CEREBROVASCULAR ACCIDENT. On 01-Apr-2021, MIGRAINE (migraine), FATIGUE (fatigued kicked in, very tired,exhausted), NAUSEA (nauseated) and VOMITING (throwing up) had resolved. On 09-Apr-2021, CEREBROVASCULAR ACCIDENT (stroke) and BLINDNESS TRANSIENT (Completely lost vision in right eye which came back) had resolved.        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.   Treatment reported during hospital included IV blood thinner ,Xarelto 20mg. Metoprolol Tartrate 25mg, Amiodarone 200mg, after second dose.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-076248 (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 these events, a causal relationship cannot be excluded.  .
4/13- itching began in perineal area. 4/14- blisters appeared. Burning and itching. 4/15- more blisters, more burning and itching. 4/16- ER trip. Tested for herpes and other STIs. Given Valtrex and Lidocaine. - set f/up appointment with OB/GYN ()on Wed 4/21/21 4/17- area slightly improved. 4/18-  Negative results  on tests. Area slightly improved.
@ 0730 Received flu Shot   0830 Complained of arm pain (deltoid area)        Chills and diarrhea  @ 0900 light headed        pain and tingling down arm @ 0915 Taken to hospital Treatment: Received I.V. for about an hour and released.
None. The Health Department noted that this dose was in the refrigerator at 39 degrees 12 days past the end date. The office was not aware that Moderna in the refrigerator had to be used within 30 days. The patient had no adverse outcome.
This prospective pregnancy case was reported by a consumer (subject) and described the occurrence of vaccine exposure during pregnancy in a 27-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) for prophylaxis during pregnancy. A physician or other health care professional has not verified this report. The subject's medical history included cut finger. Per the reporter, she received BOOSTRIX as "prophylaxis after cut on finger". There were no past pregnancies. The subject was not using contraception and the conception was normal. There was no evidence of defect from prenatal testing. There was no maternal and paternal history which may have an impact on the outcome of this pregnancy. On 17 December 2013 the subject received a dose of BOOSTRIX (.5 ml, injection, left arm) and experienced vaccine exposure during the 2nd trimester of pregnancy. The gestational age per the subject was 6 months (24 weeks). The date of last menstrual period was unknown. The estimated date of delivery was reported as 10 April 2014. Diagnostic tests included the following on unknown dates: ultrasound examination, amniocentesis, and Alphafetoprotein normal (maternal serum). There was no evidence of defect from prenatal testing. On 17 December 2013, within hours of vaccination with BOOSTRIX (described as "later that night"), the subject experienced sore arm (injection site). The subject remembered the event "because she could not sleep on her left side because of the pain." The subject reported that her "physician had told her that this might be a side effect." At the time of reporting the events were "improved a little since then." 18 June 2014- No further information was provided; patient lost to follow-up. Follow-up information was received on 19 August 2014 via subject. The subject stated she did not want any additional follow-up letters sent and is not willing to provide permission for GSK to contact her healthcare provider. No other information provided, case closed.
During the night of 12/21/15-12/22/15 I developed a large amount of swelling on my right shoulder (The site of two vaccinations). This was in addition to a red circle approximately three inches in diameter that was warm to the touch. Pain and limitation of the movement of my shoulder also developed during this time. Swelling began to go down beginning 12/27/15. Pain still persists - Slight improvement in ability to move shoulder.
This case was reported by a nurse via call center representative and described the occurrence of enlargement of lymph nodes in a 22-year-old female patient who received BEXSERO (batch number 596011A, expiry date 31st December 2018). Concomitant products included BEXSERO. On 13th September 2016, the patient received BEXSERO (intramuscular). In September 2016, less than a week after receiving BEXSERO, the patient experienced enlargement of lymph nodes, headache, fever and vomiting. On an unknown date, the outcome of the enlargement of lymph nodes, headache and fever were recovering/resolving and the outcome of the vomiting was unknown. The reporter considered the enlargement of lymph nodes, headache and fever to be probably related to BEXSERO. It was unknown if the reporter considered the vomiting to be related to BEXSERO. Additional details were received as follows: The reporter was told about a female veterinary student that received two doses of RABAVERT fro pre-exposure. On 6th September 2016, the patient received the first dose on her right deltoid. The patient received the second dose on her left deltoid. Within 48 hours of received the second dose, the patient experienced swollen lymph glands, fever, vomiting, and headache. The patient went to an urgent care facility for treatment. The reporter was unable to provide any further details at the time of the call. The call was transferred to Medical information.
Febrile Seizure, Tmax 102F, 911 called, brought to local hospital, treated with acetaminophen, no recurrence
This case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included MMR II (non-gsk); Merck; unknown given on 4 June 2009; ADACEL (non-gsk); Sanofi; given on 4 June 2009. Concurrent medications included Blood pressure medication. On 4 June 2009, the subject received 1st dose of TWINRIX (unknown, right arm) and experienced vaccine exposure during pregnancy. Immunization series was discontinued. The reporter stated that prior to receiving the TWINRIX vaccine; the subject was given a pregnancy test. The "line initially showed up but then went away". The subject stated that she was just about to start her period, so the vaccine was given. The subject took a pregnancy test within two to three days of receiving the TWINRIX vaccine, and the test came back positive. The reporter stated she thought the subject mentioned that she was on a blood pressure pill but she could not remember for certain, and she did not know the name of the pill. Also, with the concomitant MMR and Tdap vaccines that were give, she did not know the brand names. Follow up received from reporting healthcare professional on 20 July 2009: The subject's last menstrual period occurred on an unknown date. The conception was reported as normal. On an unknown date the subject started spotting and experienced miscarriage. This case was assessed as serious (potentially medically serious) by GSK. The subject was treated with dilation and curettage on 14 July 2009. At the time of reporting, the outcome of the events was unknown.
Seen in Er on 2APR91, t102.7, spitting up milk, seen by MD next morning t97; dx feb secondary to vax;
Woke up three hours later with swelling on site injection size of a clementine and severe pain in whole arm. Consulted Doctor by phone following morning. Low-grade fever of 37.7 C began within 24 hours and lasted until 48 hours after injection. Pain of swelling abated greatly with the onset of fever. The swelling  resolved into red, flat, irregular around injection site, resembling the irritation of a bee sting.
Pt. states that after receiving the 3rd dose of Booster Moderna 11/10/2021 (High-Dose Influenza 11/10/2021), started experiencing symptoms 11/13/2021 of swelling under the right arm, dizziness, nausea, vomiting, muscle aches, and fatigue. Symptoms have subsided. No noted Primary visit/communications.
Chronic fatigue, chronic headaches, chronic dizzy spells, chest pain, PVC's, fever, muscle aches, mood swings, memory loss, burning sensations on skin, etc. PT suffers from a multitude of other symptoms, but the above are the most predominant.  PT did not seek medical attention until after arriving home from his deployment.  Started having intermittent headaches, but they have been constant since January 26th, 2008 - 2 days after arriving back home.
difference with her nose; This case was reported by a consumer via call center representative and described the occurrence of nasal discomfort in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included malignant neoplasm of abdomen (Cancer survivor tumor in abdomen at age 57). Previously administered products included RECLAST (received on 5th october 2019).   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and an unknown time after starting vitamin d, the patient experienced nasal discomfort. The patient was treated with vitamin d. On an unknown date, the outcome of the nasal discomfort was unknown.   It was unknown if the reporter considered the nasal discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and notice a difference with her nose. For tolerances of 2nd dose, refer case US2020091772, reported by same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020091772:Same reporter
severe abdominal pain, headache, weakness, fatigue, diarrhea and vomiting .  The abdominal pain and diarrhea continued for three weeks. The weakness and fatigue continued this long as well, but some days were better and some days were worse. I did not get better each day as with the flu for example, but would "yo yo" up and down being very sick or less sick. The feeling of extreme fatigue was something I have never experienced.
Within 3-4 days of the shot I had a sharp decrease in energy.  After about 3 days I was experiencing dramatic decrease in energy and also experienced more than usual pain in my lower back, legs and feet.