chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 24-MAY-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "2", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
Shortly after vaccine, patient complained of extreme fatigue, stomach pain, sweating  and a little SOB.  I called 911, his mother agreed for me to call, 911 operator advised not to give Epipen or Benadryl, which I had on hand, said wait for EMS. They transported patient to hospital where he was found to be dehydrated per his dad, who called back to inform us.
Awoke at 12:30 a.m. (16 hours after inoculation)  with chills and sensation of skin crawling, muscle pain and leg cramps. Face, torso and arms flushed, red, and hot. Temperature of 102. Anxious and frightened, disoriented. Considered going to ER, but instead took two acetaminophen. 2.5 hours later fever was 100 and other symptoms had lessened. Went back to bed and slept with violent dreams. Awoke at 7:30 a.m. ( 23 hours after the vaccine). Symptoms much reduced, though felt very fatigued.
Information has been received from a physician concerning a patient who was vaccinated with the first and second dose of ROTATEQ (Lot numbers not reported) and each time after receiving the vaccine the patient developed diarrhea. The patient had not yet received th third dose. On unspecified dates the patient recovered from the events. Follow up information has been received from a physician concerning a 17 week old female patient (weight 24 lb and height 30 in) with no pertinent medical history and no known drug allergies, who on 04-FEB-2009 was orally vaccinated with the second dose of ROTATEQ (lot: 62953/1652X). On 11-APR-2009, the patient received the third dose of ROTATEQ (Lot: 663711/0107Y) orally. On an unspecified date after the patient received the second dose and third doses the patient experienced diarrhea. Subsequently, the patient recovered from diarrhea one day after each episode. Additional information is not expected.
Patient arrived at clinic informing that approximately ten minutes after immunization administration, she started feeling a sensation of right arm soreness with muscle tightening and right hand joints hurting. Patient informs of no longer having arm soreness with muscle tightening. After two hours, still remains with right hand joints hurting. Nurse evaluated injection site, compared both arms/hands/finger joints and no swelling observed. Right hand fingernails with less than three second capillary refill. Patient has mobility of each right hand joint. Nurse explained to patient of reporting condition and completing a VAERS form. Patient was advised to contact or see primary care physician, or attend minor or hospital emergency for evaluation. Patient informs of already calling Lupus doctor and leaving a message.
felt dizzy/so dizzy that a man sitting next to her had to grab her to steady her.; This spontaneous case was reported by a consumer and describes the occurrence of   in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (past medical history not provided).    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.
At 10:30am, my period (which had ended Wednesday) restarted. I don't know if this is related to the vaccine, but it has never happened to me before.  ARound 11:30am, I experienced a series of the most intense anxiety attacks I've ever had (I do have occasional anxiety attacks but not to this degree or duration), this went on for about an hour until I finally took half of a Xanax. My preferred methods of meditation, deep breathing exercises, and using essential oils didn't work, I haven't had to take a Xanax in over two years as these methods have prevented the need previously. It's been several hours and I still have a lingering sense of "doom" but haven't had another episode.
Patient had induration involving Left deltoid extending up neck and into clavicle. Mild warmth to touch.
12-14 days after vaccination broke out with chicken pox lesions on trunk, face, neck lasted over 1 week
This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that one of his patients stated that after receiving SHINGRIX experienced arm hurt more than any other vaccination ever had.
Subjective and objective fever with temp up to 102. Chills. Localized skin reaction over injection site - 4 cm circle of erythema.
After receiving the shot my arm was sore for just one day.  About 12 days later, the site of the shot started itching.  Upon looking at it noticed that it was/is red, warm and feels like a lump in the middle.  The red site is approx. 6cm x 7cm
No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 50-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 29-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 29-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date).    Concomitant drugs were not reported.  It was reported that the monovalent vial of 5.5 ml size was not exposed to temperature excursion. It was unknown when the vial was initially stored in refrigerator.  The fridge expiration date was reported as 03-Feb-2023, the website expiration date was 01-Apr-2023 and the pharmacy reported date was 30-Apr-2023.  Treatment medications were not provided.
Tested positive for covid virus in Jan 2022. Since then have been experiencing chest pains, dizziness, POTS syndrome, irregular HR.
Bowel obstruction; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4420988-00.  A 26-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 01Nov2017 (ongoing) (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Single), for Covid-19 immunization; Bnt162b2 (Dose 1, Single), for Covid-19 immunization. The following information was reported: INTESTINAL OBSTRUCTION (medically significant) with onset May2022, outcome "recovering", described as "Bowel obstruction". The action taken for adalimumab was dosage not changed.  The reporter considered "bowel obstruction" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of intestinal obstruction. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Moderate pain in neck; by morning pain in shoulder; mid day 3/5/11 rash began to appear; severe pain in upper back and shoulder, rash spread to right arm; right arm is inoperable
Child received H1N1 vaccine - IM R deltoid immediately fell to floor, color pale, diaphoretic - unconscious x 5 seconds - woke parents state child did not eat. Child ate crackers. drank water.
CHEST TIGHTNESS; INTERMITTENT HEADACHES; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included basilar artery thrombosis, and vertebral artery thrombosis, and concurrent conditions included non-smoker, and other pre-existing medical conditions included no illicit use of drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included . On 12-APR-2021, the subject experienced chest tightness. On 12-APR-2021, the subject experienced intermittent headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intermittent headaches, and chest tightness. This report was non-serious.; Sender's Comments: V0; MAC Comment  is not required for non serious case as per standard protocol.
shortness of breath that is worsened over the past week.  Patient states he has been having a very productive cough.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2010, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) a health department (by an unspecified healthcare professional) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Approximately 30 minutes after vaccination I started wheezing + coughing. My asthma is exacerbated since then.
MOTHER REPORTS CHILD HAS CHICKEN POX. PT WAS SEEN IN OFFICE ON 06/16/2011 AT 11:00 AM BY DR. AND IT WAS CONFIRMED THAT HE DOES HAVE THE VARICELLA VIRUS.
Breakthrough COVID illness; Breakthrough COVID illness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 03Jan2022, outcome "not recovered" and all described as "Breakthrough COVID illness". Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Headache, Seizure, Myalgia, Arthralgia, Fever,  ANOREXIA X 2 DAYS, MORNING AFTER DOSE 2: "PASSED OUT, HAD SEIZURE, AND LOST BLADDER CONTROL"  Narrative:
hot flashes; sweating.; hot; it feels like going to menopause; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes), HYPERHIDROSIS (sweating.), FEELING HOT (hot) and MENOPAUSE (it feels like going to menopause) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HOT FLUSH (hot flashes), HYPERHIDROSIS (sweating.), FEELING HOT (hot) and MENOPAUSE (it feels like going to menopause). At the time of the report, HOT FLUSH (hot flashes), HYPERHIDROSIS (sweating.), FEELING HOT (hot) and MENOPAUSE (it feels like going to menopause) outcome was unknown.
injection site pain, headache, muscle pain, chills, joint pain, and nausea. Started 0300 02 Feb 21, ended 1000 02 Feb 21.
Information has been received from a 45 year old female consumer with high blood pressure, high blood cholesterol and drug allergy to doxycycline referring to herself. On 07-DEC-2016, the patient was vaccinated with GARDASIL 9, (1 dose, intramuscular, lot number and expiration date not provided) for the prevention of the recurrence of HPV, which was other-than-indicated in the prescribing information. Concomitant therapies included ZOLOFT, mesalamine, lisinopril(manufacturer unknown), LAMICTAL and atorvastatin. On 07-DEC-2016, her arm with the injection site was sore. She did not seek medical attention and there was no lab diagnostics studies performed. The outcome of injection site pain was reported as recovering/resolving. The outcome of other events was unknown. Additional information has been requested.
Patient developed lower left arm cellulitis just above her elbow on the inside of the arm. She was prescribed doxycycline Hycylate 100mg Tablets 1bid for 10 days and Prednisone 20 mg Tablets 6 day taper, 60mg days 1+2, 40 mg days 3+4 20 mg days 5+6.
PATIENT STOPPED IN CLINIC ON 11-5-08 WITH REDNESS ON THE LEFT DELTOID. THIS IS WHERE HE RECEIVED HIS VZV #2. REDNESS WAS 3CM BY 3CM, RAISED, AND WARM TO TOUCH.
the ability to take and sustain a deep enough breath to sustain oxygen level ONLY when reclining for sleep.  During the day, while ambulatory, vertical or sitting, my breathing is normal.  As soon as, immediately, when I get into bed for sleep, my breathing is immediately restricted so I cannot maintain lying down.  I have to sit up.  I can't sleep.  I get exhausted by 3-4-5 a.m. and finally am so distressed I sleep in a sitting up position or catch a snippet of sleep up to an hour or so.  Often wake up with panic attack of suffocating, sit up, jump out of bed, get vertical.
pain in his arm; Flu like symptoms; This is a spontaneous report from non-contactable nurse via Pfizer Sales Representative. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration, administered in arm  on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that,  Caller is a representative for the company, and was in conversation with nurse, and informed her, though  caller does not have details, but the reporter's husband received the Pfizer COVID 19 vaccine and experienced pain in his arm and flu like symptoms the next day. Patient details: initials, age of onset, date of birth,  height, weight and ethnicity are unknown. The reporter didn't explicitly say her husband was in the country, but didn't say he was out of the country. Dates and outcome unknown, the reporter just said it was the following day, caller believes the reporter said it was the first dose. The outcome of the events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Woke up with eyes swollen almost shut, red rash all around eyes. Blurry vision, eyes feel like they are on fire. Skin on eye lids are peeling. Fever and chills
This spontaneous report was received from a healthcare worker (who is a medical assistant) refers to an unspecified patients of unknown age and gender. The patients medical history and concurrent conditions were not reported. The healthcare worker reported that multiple unspecified patients were vaccinated with improperly stored M-M-R II lot # K002527 exp: 18-FEB-2016. The vaccine was stored at 47F and administered within a time from of 10 minutes. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
10/21/2021 I noticed there was a spot on my scalp that was a little itchy. It would never heal. It would ebb and flow, get a little better and a little worse. Not enough to raise my suspicion. In June of 2022, I went to several doctors. I went to a Dermatologist on 7/18/22 and it was a cancer above and beyond what they could do. I was referred to a different Dermatology clinic and on 9/26/22, I had an 8 hour and 15 minute procedure. They would remove and look under a microscope and continued doing that during the procedure. I had a follow up on 11/2/22 and another spot was found and treated in the office. I have recovered.
Burning, itching, redness, pain in arm, stiff joints, swelling, extreme tiredness, diarrhea,chills
administration of expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 61-year-old female patient who received HAV (Havrix) (batch number unknown, expiry date June 2022) for prophylaxis.   On 17th October 2022, the patient received Havrix. On 17th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comment: The reporter stated that a administration of an expired dose of Havrix to a patient.  The reporter asked if the patient had to be re-vaccinated. The reporter did not provide the lot number but confirmed that the expiration date of the dose administered was June 2022. The reporter gave consent to follow up. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
This is a spontaneous report from a contactable medical assistant via a Pfizer sales representative. This medical assistant reported similar events for 3 patients. This is 1st of three reports. A patient of an unknown age and gender received PREVNAR 13 (LOT S06823, Exp. date May2018) at single dose for immunization on an unknown date. Medical history and concomitant medication were not reported. On an unknown date the patient experienced cellulitis. The outcome of the event was unknown. It was reported that some pneumococcal 13-val conj vaccines contained a white substance, however it was unknown if the patient had received or not the same LOT which had the white substance. Sender's Comments: Linked Report(s): US-PFIZER INC-2017327829 Same reporter/drug/event, different patient; US-PFIZER INC-2017327828 Same reporter/drug/event, different patient.
This case was reported by a consumer and described the occurrence of flu-like symptoms in a female patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced flu-like symptoms. On an unknown date, the outcome of the flu-like symptoms was recovered/resolved. It was unknown if the reporter considered the flu-like symptoms to be related to Influenza vaccine. Additional information: The patient was vaccinated about 10 years ago. Please refer to case US2014GSK019593 for tolerance to next vaccination.
Injection site became hard, itchy, and red 1 week post shot. About the size of a golf ball. Mild pain.
We gave this young man a flu shot in our office and he had already recieved one elsewhere this season from a pharmacy. There was no adverse reaction .
Pt recvd vax & devel abdo pain, nausea & diarrhea following vax;
I had fever, chills, cough, loss of appetite, loss of taste. I didn't know what was happening with me. I did a COVID-19 home test which was negative. I knew something was happening to me so I contacted my doctor. When I went to my doctor's office he did a COVID-19 test. I was positive for COVID-19 but I was negative for flu. My doctor scheduled an appointment for me to go to the hospital to get infusion. After a few days of getting the infusion I felt better and I recovered from COVID-19 infection. I just wanted to let you know after each COVID-19 vaccines I've got sicker and sicker not sure why.