chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I took my son to the doctor's office for a routine checkup for school.  Doctor said my son should have the Hepatitis A vaccine series and he received his first shot during the same doctor's visit.  My son was calm during the administration of the shot.  He has taken many other shots and never had a psychological problem with needles.  He was not apprehensive at all.  He put his shoes on, we walked out of the consultation room and while waiting for the elevator, less than 3 minutes after receiving the vaccination, my son did not look well and I asked him.  He said he felt nauseous and dizzy.  I asked him if he wanted to sit down, he said yes, and as we were turning to take the first step towards a chair, he fell to the ground hitting his forehead, the right back side of his head, and his right shoulder against another chair and the floor.  I noticed while he was on the floor, that his body twitched (convulsed?) several times before he came to.  A code blue was called and the doctors and nurses rushed to where we were.  After my son recovered consciousness he was placed in a wheelchair and taken to the same consultation room we were in.  His blood pressure was taken several times and it was very low.  My son tried getting up and walking, but he started feeling ill again and had to sit down again.  After about 20 minutes, he was taken to a room that had a bed.  He laid there for approximately 25 more minutes until his blood pressure was 120/80.  I asked my son if he had been afraid of this particular shot and he said that he had felt calmer about it than at other times.  I asked him if he remembered he had fell to the ground and he said that all he remembered was turning to walk to a chair to sit down, and the next thing he's on the floor surrounded by the nurses telling him to breathe.  This is the first and only time my son has lost consciousness in his whole life.  I voiced my concern to the doctor that I felt his fainting was a side effect of the vaccination, but he kept saying that my son was scared of the needle from the vaccination and that even football players experience this reaction to shots in general.  Since this event happened, I have done some research through the web, and found that nausea and dizziness are common side effects, however, fainting is a rare side effect and should be of concern to the patient's health.  I am against my son receiving the second shot in the series, however, my son says that he would like to try in six months and just wait a while before leaving the doctor's office.  My question to you is this:  With this reaction to the Hepatitis A shot my son received on August 9th at the doctor's office, is it safe for him to receive the second shot?  The information I was given by the doctor's nurse regarding the shot is:  Hepatitis A, VHA816A2, expiration date of 4/14/06 made by GSK (Glaxo, Smith, Kline.  I look forward to hearing from you.  Thank you.
Patient is immunocompromised.  She received 0.5 ml of the 4th dose instead of 0.25ml
I had gone in to have my annual mammogram that I had to put off early in the year, as I had, had a stroke. I let the doctor know I had found a lump on my left breast that morning before the shower. The mammogram did confirm lump on my left breast. I was then scheduled for a biopsy, that found that lump was triple negative breast cancer. I was sent to a specialist to have the lump removed and start chemotherapy. We found that I was allergic to the chemotherapy medication. I will be starting radiation in a week and half.
p/vax pt c/o lt arm inc sore; 24hr later lt upper arm red & inflamed; last 7 days; pt also doing a lot of hard labor
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-DEC-2018 , the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.; Sender's Comments:  US-009507513-1907USA000067:
REDNESS AROUND INJECTION SITE ON THE RIGHT ARM. WARM TO TOUCH. SORE WHEN TOUCHED.
Saturday 2Pm pt very hot, then noticed spots on back, tummy & face;took child to ER Saturday 7PM:MD seen in ER confirmed chickenpox;
Information has been received from a consumer referring to her mother, a 87 year old female patient. The patient's relevant medical history was not reported. On an unknown date of 2014, the patient was vaccinated with ZOSTAVAX intramuscularly (dose and lot# were not reported) (Incorrect route of drug administration). Information regarding concomitant medication was not reported. Three months later in 2014 (also reported half years after vaccination), the patient experienced shingles after receiving ZOSTAVAX. The reporter stated that the case was mild and felt it would have been worse without the vaccine. The shingles was recovered on an unknown date of October 2014. The reporter considered the shingles to be non-serious and not related to ZOSTAVAX. Additional information is not expected as the reporter refused to follow up.
Quarter size round red, swollen, warm to touch at injection site with smaller dime size round red swollen warm to touch lump 1/4" under injection site
The patient said she is having ongoing right arm pain after her 2nd Moderna shot in March. she said it is tender to the touch and aggravated by certain movements.
Ptosis, weakness, numbness, dx of Guillain Barre syndrome, treated with IVIG.
moderate to severe headache; Weakness; Lightheadedness; shaking uncontrollably without any chills; Nausea; Shoulder pain; 102.1 fever; Back spasms; Neck pain; Unable to eat; Unable to sleep; stomach pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (shaking uncontrollably without any chills), MUSCLE SPASMS (Back spasms), NECK PAIN (Neck pain), FEEDING DISORDER (Unable to eat) and INSOMNIA (Unable to sleep) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 036AZLA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heller's esophagomyotomy (hellermyotomy). Concurrent medical conditions included Asthma and Celiac disease.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced MUSCLE SPASMS (Back spasms), NECK PAIN (Neck pain), FEEDING DISORDER (Unable to eat), INSOMNIA (Unable to sleep), ABDOMINAL PAIN UPPER (stomach pain), ARTHRALGIA (Shoulder pain) and PYREXIA (102.1 fever). On 18-Mar-2021 at 7:00 PM, the patient experienced NAUSEA (Nausea). On 18-Mar-2021 at 9:00 PM, the patient experienced TREMOR (shaking uncontrollably without any chills). On 19-Mar-2021, the patient experienced ASTHENIA (Weakness) and DIZZINESS (Lightheadedness). On 20-Mar-2021, the patient experienced HEADACHE (moderate to severe headache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) at a dose of 4 milligram. At the time of the report, TREMOR (shaking uncontrollably without any chills), MUSCLE SPASMS (Back spasms), NECK PAIN (Neck pain), FEEDING DISORDER (Unable to eat), INSOMNIA (Unable to sleep), ABDOMINAL PAIN UPPER (stomach pain), ASTHENIA (Weakness), DIZZINESS (Lightheadedness), NAUSEA (Nausea), ARTHRALGIA (Shoulder pain), PYREXIA (102.1 fever) and HEADACHE (moderate to severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 102.1 (High) Fever.         No concomitant medications provided.   This case was linked to MOD-2021-051475 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Additional information received included no new significant information
Approximately 1 day after the 1st dose, the patient noticed painless swelling of distal joint on his right hand. No change in color, not warm or cold to touch. Symptoms have persisted and are present on presentation for dose 2. Digit appears swollen over the distal joint but without discoloration, pain, or warmth/cold sensation relative to other digits/hand. Skin intact without obvious signs of infection. Patient states he presented to the Emergency Department (ED) for another complaint on 4/7/2021 and also asked them to evaluate his finger. No additional workup was done besides asking questions related to gout.
Cellulitis/swollen and redness at the administrated site/the upper left deltoid/It is indurated and erythematous; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: AG8353, expiry date: Jun2021), via an unspecified route of administration on 25Oct2019 at single dose in left deltoid for immunization. There is no medical history. Concomitant medication included influenza vaccine (FLU) on 25Oct2019 at single dose in right arm for immunization. It was reported that the patient experienced swollen and redness at the administrated site, there was a 3cm diameter oval to the extremity; the upper left deltoid, it was indurated and erythematous, it was tender and very warm to the touch, there was no fluctuance, drainage, or bleeding, it was a localized reaction. Date this started was unknown but the patient was seen in the office and diagnosed with cellulitis on 28Oct2019. Cellulitis was reported as serious per medically significant. The patient was treated with cefalexin (CEPHALEXINE) (500mg capsule for 1 by mouth twice a day for 10 days, given a quantity of 20) for this diagnosis. The outcome of the event was not resolved at time of the report.; Sender's Comments: Based on the information currently available, the vaccination with PREVNAR 13 might have played a contributory role in triggering the onset of cellulitis localized at the vaccination site.  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
Was diagnosed with bursitis for 3 weeks after receiving first covid 19 vaccine either due to improper vaccine admission or due to the vaccine itself. Pain in shoulder joint radiating to finger tips, collar bone and shoulder blade. I did call doctor 4 times. Recommendation was ibuprofen 800 mg 3x a day, ice, heat and continual movement of shoulder
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with the second dose of GARDASIL (lot number not provided). The 2nd dose of GARDASIL had been administered outside of the prescribing information, an unspecified date to the patient 6 months after 1st dose. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Patient experienced neck pain or "neck tension" EMS was called vitals came back normal and released to go home.
Nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and FATIGUE (fatigue) 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.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and FATIGUE (fatigue). At the time of the report, NAUSEA (Nausea) and FATIGUE (fatigue) outcome was unknown.            No concomitant and treatment medication details were provided.
Approx. 20 minutes, post vax, the pt stated that she "didn't feel right". She complained of being "bright red" all over. She complained of nausea, epigastric pain and tingling in all extremities. No SOB. BP was 91/70; Pulse was 100. She was given Benadryl 25mg at 10:00. At 10:30, there was no improvement and EMS were called. The pt was transported to the hospital at 10:50. Her eyes were bloodshot. She was treated with Zantac, Benadryl and prednisone at the hospital.
Can only verify that the patient has had their 1st dose of Moderna on 2/8/21, and then received only a half dose/booster for their 2nd dose.
migraine; nausea; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable female consumer (patient) reported for herself that, she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown)  via an unspecified route of administration on 11Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was currently experiencing migraine. She was asking if she can take Migraine pills for her migraine. Upon follow up received on 11Apr2021: This is a follow up spontaneous report received from a Pfizer Sponsored Program. A contactable female consumer (patient) reported for herself. Upon follow up received on 13Apr2021, patient received Pfizer Covid-19 vaccine first dose 11Apr2021 and experienced migraine and nausea. Wanted to know if she can take Ibuprofen or is there any medication that would affect the effects of the vaccine. The outcome of the evets was reported as unknown. The action taken in response to the events for bnt162b2 was not applicable.   Follow up received on 11Apr2021: This is a follow up spontaneous report received from a Pfizer Sponsored Program. A contactable female consumer (patient) reported for herself. No new information was received.  Follow up received on 13Apr2021: Events was added (nausea). New information was added.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pfizer vaccine was administered outside of facility - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------- J96.00 ACUTE RESPIRATORY FAILURE 4/4/2023 DM 2 W HYPERGLYCEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/28/2023 DM 2 W HYPERGLYCEMIA J96.00 ACUTE RESPIRATORY FAILURE 4/4/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/28/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 4/4/2023 ANEMIA OF CHRONIC DISEASE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/28/2023 ANEMIA OF CHRONIC DISEASE
Patient had an injection site reaction starting the morning after receiving immunization. The injection site area was red, hot to the touch, hard/swollen, and painful. These symptoms have persisted til today. She is using ice, ibuprofen, and acetaminophen to  help with pain and swelling.
I got COVID-19 on 11/21/2021, 01/21/2022 and 05/05/2022.  In Nov, I was extremely fatigued.  In Jan, I experienced extreme vomiting.  In May, I have experienced a dry, persistent cough.
Pain in arm; chip in the vaccine moving around in my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and VACCINATION SITE DISCOMFORT (chip in the vaccine moving around in my arm) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm) and VACCINATION SITE DISCOMFORT (chip in the vaccine moving around in my arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and VACCINATION SITE DISCOMFORT (chip in the vaccine moving around in my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.    Reporter did not allow further contact
severe headache; chills; fever as high as 103; swollen eyes; body aches; nausea; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in arm right on 08Mar2021 02:15 as dose 1, single (age at vaccination: 55 years) for COVID-19 immunisation. The patient medical history included COVID + test from an unspecified date Aug2020 to an unknown date resulted as positive. Concomitant medications included lisinopril (LISINOPRIL); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]); ascorbic acid (VITAMINS C); zinc (ZINC); calcium (CALCIUM), all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No COVID prior vaccination and did not tested COVID post vaccination. No known allergies. On 08Mar2021, the patient experienced severe headache, chills, fever as high as 103, swollen eyes, body aches, nausea started about 20 hours after shot. 3 days later still have same symptoms. Actually, had COVID + test in Aug2020 and had severe symptoms, but not hospitalized. No treatment was received. The patient underwent lab tests and procedures which included COVID + test resulted as positive on an unspecified date Aug2020 COVID + test. The clinical outcome of the events was not resolved.  No follow up attempts are possible. Information about lot/batch number cannot been obtained.
A report had been received from a Health Professional concerning a patient, female patient, who had been receiving FLUMIST Quadrivalent (Intranasal), 0.2 Milliliters. FLUMIST Quadrivalent (Intranasal) started on and unknown date. It was reported that a 19 month old patient had accidentally received FLUMIST which is considered as an off label use. The outcome of the even of Off Label use in a 19 month old received FLUMIST is unknown. The reporter's description of the event(s) was as follows: no medical history, no medications listed. The report was considered to be non-serious.
Swelling shoulder and arm, numb fingers, chills, body aches, extreme fatigue, fever 102 16 hours, continuing fatigue, lack of strength, sweating, thirst.
This spontaneous report was received from a pharmacist regarding a 71 year old female patient. Patient had no pertinent medical history or drug allergies. On 04-MAR-2015, the patient was vaccinated with ZOSTAVAX (lot and expiry date were not specified) 0.65 ml, once, subcutaneously. There was no concomitant medication reported. On an unknown date (recently), the patient was diagnosed with shingles (vaccination failure) for which the primary physician ordered anti-viral medication. The reporter had accepted the VZV packet. There were no lab diagnostics performed. Outcome of vaccination failure was unknown at the reporting time. There were no Product Quality Concerns (PQC) involved. The reporter did not assess the causality of the event with ZOSTAVAX. Additional information has been requested.
Boils on underarm and groin area; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of FURUNCLE (Boils on underarm and groin area) and HEADACHE (Headaches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa and ACITRETIN for Pustular psoriasis.    Concurrent medical conditions included Pustular psoriasis and Hidradenitis suppurativa (Moderate to Severe Hidradenitis Suppurativa).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and ACITRETIN (Oral) 25 milligram. On an unknown date, the patient experienced FURUNCLE (Boils on underarm and groin area) and HEADACHE (Headaches). At the time of the report, FURUNCLE (Boils on underarm and groin area) outcome was unknown and HEADACHE (Headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2022, Computerised tomogram: found nothing.         No concomitant medications were reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial or not.  The reporter causality for the event of headaches was reported as reasonable possibility with respect to co-suspect Acitretin and for the event of boils on underarm and groin area was not provided with respect to co-suspect Acitretin.  The reporter causality for the events of headaches and boils on underarm and groin area was not provided with respect to co-suspect Acitretin.  No treatment medications were reported.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.No Medical History information was reported. On 23-Oct-2021 at 1:48 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Oct-2021 at 1:48 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 23-Oct-2021 at 1:48 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided.For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant medication details were not reported by the reporter.Treatment details was not reported by the reporter. It was reported that none of the patients have reported any adverse reactions as of 19-NOV-2021.This case was linked to MOD-2021-363223 (Patient Link).Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Initial additional document received contains patient demographics and vaccine information.
CHILLS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious.
Pt recvd DTP/OPV 21NOV90, then devel fever 105 & sz; Taken to ER given suppos; Not admitted to Hosp