chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had an intrauterine fetal demise at 36 4/7 weeks. Most likely unrelated but want it reported that she had vaccine during pregnancy.
Due to the temperature for the month of October 2018 not being done on the data logger and manual temp logs the vaccines will be deemed unviable.
tested positive for COVID after receiving the COVID vaccine; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported same event for three patients. This is the second of three reports.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 16Feb2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID after receiving the COVID vaccine. The patient had the COVID vaccine this morning (16Feb2021) and tested positive for COVID on 16Feb2021. The reporter made a comment about the patient being "cuckoo in the head". The outcome of the event was unknown.  Information on the lot/batch number has been requested
Got the vaccine done but I suffered this all through /suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the vaccine done but I suffered this all through /suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The patient was treated with chemotherapy, nos (Chemotherapy). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-JUN-2023 This case was reported by a patient via interactive digital media. The patient stated that she/he got the vaccine done but suffered this all through. Patient had to go to his/her country and there they performed a kind of chemotherapy in the front. They invented serums and vitamins, vitamin, the patient did not remember. Patient was fine, just had a little bit of it, not much, but it was like before. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
This is a spontaneous case, initially received from a pharmacist on 14-Dec-2017, concerning a 59-year-old adult male patient. The patient's medical and medication history were not reported. On 14-Dec-2017, the patient was administered partial dose of FLUVIRIN (dose: less than 0.5ml, batch no: 179904P, expiry date: 20-May-2018, route of administration: intramuscular, anatomical location: deltoid), as vaccine leaked onto the patient's hand during administration . It was reported that, the vaccine leaked through the locker device (around needle attachment), but when a different needle was attached, again leakage was noticed. There were no signs of damage on the needle and appeared to be tightly attached. It was confirmed that leakage was due to a user error. The patient was administered with another dose of vaccine. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding product technical complaint (PTC) reference number was 1026643. Batch investigation report received from quality assurance department, that PTC was raised following a report of 2 leaking syringes of FLUVIRIN batch 179904P, although the complainant later confirmed that the leakage was due to a user error. Therefore, no investigation was performed, and the root cause was assigned as user error, and the case was not justified. It was reported that, the patient had not experienced any adverse effects. The reporter assessed this case as non-serious. Follow up received from Quality assurance department on 15-Jan-2018 and from reporter on 02-Feb-2018 (combined report): Added event drug administration error, as the patient received second dose. It was confirmed that the patient administered FLUVIRIN via intramuscular route in deltoid. Added QA investigation of FLUVIRIN batch. It was confirmed that the leakage was due to an user error, no investigation was performed. Narrative amended accordingly. Update received on 11-Nov-2018: Non-significant case correction (IRD: 14-Dec-2017): The term was changed from 'Technical complaint number' to 'PTC reference number' in notes section of additional information tab.
Patient received Pneumovax instead of Prevnar; on 09-MAR-2019 the pt received Pneumovax 23/ she had prior Pneumovax 23 4 years prior; splenoctomy; This spontaneous report was received from a health professional also reported as vaccine coordinator and refers to a 31-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 15-APR-2015, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dose, route, site of administration, lot number and expiration date were not reported) for prophylaxis.  On 08-MAR-2019, the patient underwent a splenectomy in a large hospital (no further information provided).  On 09-MAR-2019, the patient was vaccinated with another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dose, route, site of administration, lot number and expiration date were not reported) for prophylaxis when she was supposed to receive pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (dose, route, site of administration, lot number and expiration date were not reported) for prophylaxis.  On an unknown date in May 2019, reported as about 2 months post operation, the patient was supposed to receive second dose of unspecified serogroup B meningococcal vaccine, second dose of unspecified meningococcal ACYW polysaccharide vaccine (dates of first doses were not reported) and another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). However, the healthcare professional decided that the patient would not receive pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) again since she had been already vaccinated on 09-MAR-2019. At the time of reporting, the healthcare professional was wondering if it would be safe for the patient to receive pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) now.   The outcome of the event was unknown. The causality between the event and the suspect therapy was not reported.  Upon internal review, the event of splenectomy has been upgraded to medically significant.
Two days after getting the 2nd dose, I noticed the lymph nodes on the right side of my body and under my armpit were swollen and tender. They got bigger and more tender days later. I went to see my doctor. The doctor felt that they were very hard. He gave me an antibiotic. Over time, the lymph nodes became smaller after taking the medication. However, sometimes the lymph nodes become inflamed and red.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Slight heavy feeling of tongue, which went away after a few mins-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. No information on the patients' concomitant medications, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB, lot # L014427 with expiry date on 09-MAR-2018, lot # L030869 with expiry date on 08-JUN-2018, lot # L042836 with expiry date on 24-AUG-2018, and lot # N001348 with expiry date on 31-OCT-2019 (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 35.2 degrees Fahrenheit for 15 days. Data logger was involved in recording the excursion details. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007335: US-009507513-1709USA007336.
Information has been received from a Nurse practitioner for the pregnancy registry for VARIVAX (Merck) concerning a 35 year old female patient with a history of malaria at age 9 and no drug allergy who on 25-AUG-2009 was vaccinated with VARIVAX (Merck) and MMR II. Other concomitant therapy included FLONASE and pre natal vitamins (unspecified). On 25-AUG-2009 the patient was vaccinated with VARIVAX (Merck) and MMR II and was pregnant. The patient took a urine home pregnancy test and it was positive. The patient was vaccinated at another facility, so nurse practitioner stated she does not have all the details at the time. The patient went to the office on 03-SEP-2009. The patient sought unspecified medical attention. Follow up information received from an administrative manager indicated that the patient had not been seen at this office since her visit on 03-SEP-2009. The patient transferred to another clinic. The manager attempted to locate some patient information, since both offices were part of the same health system, and she saw information in the computer dated 13-APR-2010, she indicated that the patient was 16 weeks and 1/7 days pregnant. This gestational age was not compatible with the LMP given (31-JUL-2009). The manager indicated that she didn't see other information that would explain the discrepancy at the moment. The patient was scheduled for her next prenatal visit on 12-MAY-2010. Follow up information was received from an OB nurse at the OB clinic. According to the nurse who had access to the patient's chart and was able to clarify the pregnancy dates (the nurse indicated that the patient's original pregnancy was reported with a LMP of 31-JUL-2009). The nurse reported that the patient and her husband had an unplanned pregnancy and she was worried about having gotten VARIVAX (Merck). The patient and her husband met with the nurse practitioner to discuss their concerns, their options were discussed, and they chose to terminate the pregnancy. She had the termination in "the fall, sometime in September 2009", the patient recovered without problems according to the nurse practitioner. The patient then called to ask how long after the vaccine they needed to wait to conceive. She came to the office for a new OB visit on 17-FEB-2010. That was her fourth pregnancy; she had two living children. She had an early transvaginal ultrasound for dating on 16-MAR-2010, due to irregular menses with an LMP of 29-DEC-2009, and the ultrasound confirmed and estimated delivery date of 27-SEP-2010. In this pregnancy both she and her husband were having hemoglobin electrophoresis labs drawn, though the nurse was not sure what the patient's ethnicity was, or why she was having that done. Upon internal review they chose to terminate the pregnancy- elective termination- was determined to be an other important medical event. No further information is available.
On the evening that the pt got the vaccine, she started feeling chills. Over night, pt got dizzy and fainted onto the floor which caused her to fall and resulted in bruising on her body.
Patient reports case of SIRVA.  She reports pain at time of injection and no improvement since that time.  Oral  acetaminophen and ibuprofen provide limited relief. Ice packs help when possible to use them.  Patient relayed the problem when receiving second dose. She states that the first dose was given about one-half inch below prominent shoulder bone (Acromion or possibly  the Subdeltoid bursa)
Vaccine best used by date expired.  Vaccine was taken out of the refrigerator by staff and it was not noted that the vaccine had expired.  Vaccine was administered to the patient.  No reaction was had by the patient.
Arm tight like a sunburn; Arm hot to the touch; Big red circle; Arm pain; Covid arm; Left arm a little splotchy; Left arm felt weird; Arm felt tight; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DYSAESTHESIA (Left arm felt weird), VACCINATION SITE MOVEMENT IMPAIRMENT (Arm felt tight), RASH ERYTHEMATOUS (Arm tight like a sunburn), VACCINATION SITE WARMTH (Arm hot to the touch) and VACCINATION SITE BRUISING (Big red circle) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE DYSAESTHESIA (Left arm felt weird) and VACCINATION SITE MOVEMENT IMPAIRMENT (Arm felt tight). On 18-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Arm tight like a sunburn), VACCINATION SITE WARMTH (Arm hot to the touch), VACCINATION SITE BRUISING (Big red circle), PAIN IN EXTREMITY (Arm pain), VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE RASH (Left arm a little splotchy). The patient was treated with MELOXICAM on 18-Mar-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DYSAESTHESIA (Left arm felt weird), VACCINATION SITE MOVEMENT IMPAIRMENT (Arm felt tight), RASH ERYTHEMATOUS (Arm tight like a sunburn), VACCINATION SITE WARMTH (Arm hot to the touch), VACCINATION SITE BRUISING (Big red circle), PAIN IN EXTREMITY (Arm pain), VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE RASH (Left arm a little splotchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products reported.
I have a swollen and red circle about a half inch from my injection site that isn?t going away. It is still sore to the touch. It was very hot to the touch for 3 days following the injection but the heat went away.
rash on his chest, right elbow, and legs.; This case was reported by a consumer via call center representative and described the occurrence of rash in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included eczema.   On 2nd January 2020, the patient received the 1st dose of Shingrix. On 16th January 2020, 14 days after receiving Shingrix, the patient experienced rash. The patient was treated with medication unknown (Cream (Medication Unknown)). On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experience rash on his chest, right elbow, and legs.  The patient used an over the counter cream that seemed to help, but has not fully resolved at time of report. The reporter did not consent to follow up.
Mother states child had convulsion at night after immunization. Paramedics arrived at home. Child had increased temp. Child taken to ER. Mother states doctor told her convulsion was due to immunizations. Was discharged, all tests were negative.
Noticeable fatigue ongoing since the vaccinations; This is a spontaneous report from a contactable nurse, the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249) via an unspecified route of administration in the left arm on 19Jan2021 at 18:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN) and allergy to penicillin. Concomitant medication was not reported. The patient previously received naproxen (NAPROSYN) on an unknown date taken for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 the patient experienced noticeable fatigue ongoing since the vaccinations. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event noticeable fatigue ongoing since the vaccinations was not recovered at the time of this report.
The rash began April 24, 2021 at the injection site of my left upper arm after receiving the 1st dose of the vaccine on  April 17, 2021. I received a first dose of Benadryl for the rash but there was no change. The rash and site kept growing. I continued with Benadryl, but there was still no change. I had mild itching, but there wasn't any pain. I was able to move my arm with no pain. I had no fever, chills, or lethargy. I have never had any allergic reactions to vaccines in the past. I didn't have any throat or facial swelling. I was prescribed a cream called triamcinolone that was applied twice daily as needed for my rash. It helped, and it cleared up the rash within 10 days.
Allergic reaction about 10 minutes in car after vaccine given. No monitoring done at Pharmacy. Facial swelling with rash and hives on neck, chest, back, and arms. I am a nurse and monitored myself, drove home and took Benadryl. No EPI pen available. I am currently still taking Benedryl at night and Loritadine during the day due to continuing rash. Other signs and symptoms nausea, vomiting, headache, fatigue currently.
positive COVID-19 test with symptoms; positive COVID-19 test; gastritis; diarrhea; This is a spontaneous report from a contactable other hcp (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685; expiry date was not reported), via an unspecified route of administration on the upper right arm on 21Dec2020 at single dose for COVID-19 immunization.  Medical history included blood pressure high, attention deficit hyperactivity disorder (ADHD), hypertension all from an unknown date and unknown if ongoing, and was a former smoker. Concomitant medication included lisinopril and methylphenidate. The patient reported that after he received the vaccine, he tested positive for Covid on 30Dec2020. The patient further reported that he ended up getting significant gastritis on Christmas Eve, which he didn't think about acquiring COVID, he had had the vaccine, he ate a bunch of holiday fare, so he thought he had got a stomach bug or something like that. He says he had considerable diarrhea on Christmas morning, but no fever or chills, then those symptoms resolved by Saturday, and he didn't think about it, he didn't have any issues. He says that he went to get tested, which they do frequently, and his temperature was checked frequently at the places he goes and he had no fever, and is still not febrile now. He says that he gets a weekly COVID test which allows for him to enter different facilities, and this was the first time in 9 months that he tested positive since this all came out. He says he has worked in some heavy duty places, but he wears his PPE, his respirator, his shield, and still did this stuff after he got the vaccine, he didn't let his guard down since it might take a while for immunity to kick in, but he still didn't think that it could be possible to have COVID on Christmas Eve, he was rather surprised he was positive. The patient confirms that he hasn't had the second dose of the vaccine yet. He says that his diarrhea improved on day or two starting after he had been having bloating on Christmas Eve and Christmas morning. He says his diarrhea resolved, he took no medication for it, and had no change in his heart rate or breathing, no problems anywhere else, he didn't feel that bad, except for the going to the bathroom. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 30Dec2020. The outcome of the events was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this subject cannot be completely excluded.  Further information like confirmative virus genome /nucleic acid detection needed for meaningful medical assessment.
Patient was due for the updated bivalent moderna booster, but was mistakenly given the monovalent moderna vaccine. As of now, the patient has no known adverse events.
Pharmacist had difficulty getting the plunger to move further and upon removing the needle from the patient's arm to examine the syringe, noticed that there was an air bubble remaining in the syringe. There did not appear to be any more vaccine in the syringe, however, the patient did have a few (1-2 drops) of vaccine on her arm at the site of injection. Our clinical department was contacted and it was determined, based on ACIP recommendations, that the patient should be re-vaccinated. The patient was contacted and declined re-vaccination at this time.
1 of 5 pts who had a reaction following vax; pt exp a rash & erythema @ the site of inject w/in 24 hrs p/vax;
Erythematous. Swelling over right leg measuring 7x7 cm (with 2x3 cm in diameter area of induration).
Muscle pain, nausea, fever, pain at injection site, chills, fever, headache, earache, extreme fatigue which have lasted over 24 hours.  Sleep and Tylenol used
arm swelling, soreness, fever, nausea, body aches, diarrhea, fatigue immediately after both doses
nausea; vomiting; Mild headache; arm was hurting/Left arm soreness; This is a spontaneous report from a contactable physician reporting for himself. A 47-years-old male patient received the second dose of  bnt162b2 (BNT162B2; Lot # EJ1686) vaccine  , intramuscular in the left deltoid on 07Jan2021 11:00 at single dose for Covid-19 immunisation .  The patient medical history was not reported.  There were no concomitant medications.  Previously on 17Dec2020 the patient received the first dose of BNT162B2 vaccine. The patient experienced nausea and vomiting  on 10Jan2021 23:59 with outcome of recovered , mild headache on 07Jan2021 20:30 with outcome of recovered , arm was hurting/left arm soreness  on 07Jan2021 20:30 with outcome of recovered.  The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative   on 20Nov2020. Nausea and vomiting were considered Important Medical Events.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events nausea and vomiting  cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
Diagnosed on 2/4/21 with a dvt blood clot in my left leg. Currently on warfarin.
Patient reported abdominal discomfort beginning in the summer of 2021.  He underwent a partial colectomy due to  diverticulitis. Labs in November 2021 revelaed significant anemia.  Patient saw a hematologist/oncologist in December 2021 and was diagnosed with a malignant gastric mass with multiple metastases.