chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came into the clinic for his booster. He had just gotten the 4th dose on 7/1/22. He told the provider it was his 2nd booster and she placed the order. The MA double checked the order was right, obtained consent, and gave patient the Pfizer vaccine in his left arm. When she started charting she realized it was his 5th dose, told the provider and notified the patient. No adverse events reported, patient was monitored for 20 minutes and then discharged.
I had some pain in my arm after the shot but worked it out with exercise.  At 2 Am on Saturday I awoke to find my arm was burning and itching.  The spot was hot, and red.  It kept getting larger until it was 2 inches in diameter.
Chest pain/heartburn, pressure in left ear with blood rushing to head, dizziness, nausea. Went to ER on 4/10. Released after EKG and cardiac enzymes ruled out MI, CT scan no PE. Told to follow up with primary care doctor. Still experiencing chest tightness, blood rushing to left side head/tingling and now tingling left leg. Seeing doctor this afternoon.
received Boostrix instead of Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 6-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 67749, expiry date 3rd November 2024) for prophylaxis.   Previously administered products included Dtap vaccine (received 2 doses on an unknown date).   On 24th August 2022, the patient received Boostrix. On 24th August 2022, unknown after receiving Boostrix, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date: 24-AUG-2022 Reporter's comments: Medical Assistant reported that patient received Boostrix instead of Kinrix vaccine.  According to Vaccine Card, there were 2 Dtap on this patient's file. According to patient's chart, there were 5 Dtaps on the system.  The reporter consented to follow up via postal.  Permission to create a GSK account in system was declined. Additional Supportive Information: Patient received Boostrix instead of Kinrix vaccine, which led to Wrong vaccine administered.
woke up 1/6/21 @ 4am with chills and nausea. Took a Zofran. Awoke again at 5am with fever of 100.6 F. Fever did not respond to 600 mg ibuprofen. Later that day developed headache and body aches. Pain at injection site present as well.
Left sided visual issues.  Went to ER, Advised that I had a stroke.  No issues or problems prior
Pt had redness, swelling and fever 101.0. Pt was treated with Benadryl and Tylenol.
received all doses before but he was tested positive recently/ tested positive for COVID; received all doses before but he was tested positive recently/ tested positive for COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "received all doses before but he was tested positive recently/ tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: he was tested positive recently/One of his friends tested positive for COVID. Clinical course: The reporter, wanted to ask about COVID-19 Bivalent availability, as his friend received all doses before, but he was tested positive recently. The reporter wanted to know when the new Pfizer COVID-19 vaccine will be available. He also mentioned that one of his friends tested positive for COVID after getting all the doses of the Pfizer Bivalent COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Eight days after vaccine, I woke up with hives around my waist.  They spread to my entire body... with major outbreaks from knees to shoulders.  Two days after the hives started, blisters started appearing on wrists and hands.  Major itching and inflammation. Treated with Benedryl,  Zyterc and 2 doses  Hydrozyzine.  Benedryl seems to be the most effective in reducing the itching.   4 days after this began, the itching reduced on the torso, but new hives and blister continue to appear.
pt exp hives w/in 90 minutes p/vax; DPH given; react resolved w/in 1 1/2 hrs;
had a temperature; she was pretty sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 immunisation, reaction(s): " was fine after the first vaccination". The following information was reported: BODY TEMPERATURE INCREASED (non-serious), outcome "recovered", described as "had a temperature"; ILLNESS (non-serious), outcome "recovered", described as "she was pretty sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had no autoimmune conditions. The day after the second dose, patient was pretty sick. She had a temperature and the classic symptoms and then was fine after.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received 2nd COVID vaccine on 02/10/2021. Started with increased redness at injection site on 2/14 and yesterday started itching. No resp issues. No other areas of redness or itching
My COVID-19 symptoms started on 03/17/2023 in the morning.  I hade fever of 100.5,  body aches, and  slight cough. On 03/18/2023 I tested  positive with a home COVID-19 test which was positive, I did a telehealth with my doctor who prescribe me Paxlovid for  5 days.  I am still testing positive as of today.
Pt received vaccine and moved to observation area without event. 12:09 pt alerted nurse that she was "feeling light-headed".  Sitting in chair, no other s/s or reaction noted.  VSS BP 135/75 (pt reports this is normal for her), HR 65, resp 12. Pt does not wish to lay on the floor and put her feet up.  Pt given water and says she feels ok sitting in the chair. 12:11 Pt reports "feeling better but still "a little light-headed, but it's better".  Pt has a history of vertigo.  She reports bouts of light-headedness with exercise that resolve within minutes by resting. She normally returns to exercise as soon as the light-headedness passes. 12:17 No change, pt continues to sip water and eating a snack.  12:26 VSS BP 132/76, HR 66, reports "feeling better but just a little light-headed".  12:35 Pt reports symptoms have completely resolved.  Pt stood, walked around, no further symptoms.  Reviewed s/s of reaction vs side effects. Pt agrees to notify 911 if any reaction symptoms appear.  Recommended pt notify pcp of this event as well as other events of light-headedness.  Reviewed pt's history, meds and today's events with site director and pharmacist.  Pt cleared to leave.  NM
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant no treatment medication were reported.   This case was linked to MOD-2021-395985.
This is a spontaneous report from a contactable other HCP (healthcare professional), the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: E11283) via an unspecified route of administration on 19Dec2021 at 12:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included "HTH GERD" and sulfa allergy, both from unspecified dates and unspecified if ongoing  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (received within two weeks of the vaccination) included pantoprazole sodium sesquihydrate (PROTONIX), losartan and anastrazole, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received demerol for an unspecified indication on an unspecified date and experienced allergy (reported as "known allergies: Eli sulfa demerol"). On 08Jan2021 at 12:00 the patient experienced severe cellulitis on trunk anterior/ posterior, elevated temp white count pain, fatigue, SOB (shortness of breath) and chest pain. All events were serious for hospitalization on an unspecified date, for 5 days. All events resulted in a doctor or other healthcare professional office/clinic visit and an emergency room/department or urgent care visit. The events required treatment with antibiotics for 6 weeks. The clinical outcomes of the events severe cellulitis on trunk anterior/ posterior, elevated temp white count pain, fatigue, SOB (shortness of breath) and chest pain were all recovered/resolved with sequel (recovered with lasting effects) on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available the reported events more likely represent intercurrent medical conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). 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.
Patient had persistent fever/temperature spikes. Patient also had induration, warmth, and erythema on left upper extremity. Per MD, fevers possibly secondary to cellulitis evolving at site of vaccine administration on LUE. Ultrasound of left upper extremity suggestive of cellulitis but revealed no collection/abscess per MD. Patient received Tdap IM at 0515 and Pneumovax SC at 1407 the previous day.
This case was reported by a physician via call center representative and described the occurrence of fever in a 22-year-old female patient who received BEXSERO for prophylaxis. Concurrent medical conditions included menorrhagia. Concomitant products included TETANUS TOXOID and OCELLA. On 5th June 2018, the patient received the 1st dose of BEXSERO (intramuscular). On 5th June 2018, less than a day after receiving BEXSERO, the patient experienced injection site tenderness. On 6th June 2018, the patient experienced fever. On 7th June 2018, the patient experienced nodule on extremity, injection site swelling and skin eruption. In June 2018, the outcome of the fever and injection site swelling were recovered/resolved and the outcome of the injection site tenderness was recovering/resolving. On an unknown date, the outcome of the nodule on extremity and skin eruption were not recovered/not resolved. It was unknown if the reporter considered the fever, nodule on extremity, injection site tenderness, injection site swelling and skin eruption to be related to BEXSERO. Additional information was received as follows: The patient also received Tetanus booster (unknown manufacturer) on the same day of vaccination on the left arm but above the injection site for BEXSERO. The patient also received Purified protein derivative (PPD) injection to test for TB on her forearm. The patient's mother reported that the patient received BEXSERO the Tuesday before the day of reporting and experienced a low grade fever the next day. The reporter reported that 48 hours after administration of BEXSERO, the patient experienced swelling on left arm around the injection site that lasted for approximately 48 hours. After 48 hours of receiving BEXSERO, the patient had two nodules on her left arm, distal to the injection site, that was erupted and then the patient had a new nodule that erupted a day before reporting day. On the same day of vaccination, the patient experienced tenderness on her left arm around the injection site. The patient has denied permission to contact their physician. The reporter stated that they do not intend to give the next dose in the series due to the adverse event experienced after dose 1. The caller stated that this patient's twin received the same series of vaccines on the same day and did not experience the same reaction (refer case US2018104366).
Administered first 2 doses of Vivotif consecutively; A spontaneous report was received from a pharmacist on 22SEP2022. It described a 65-year-old female patient who "administered first 2 doses of Vivotif consecutively" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient administered the first 2 doses of Vivotif consecutively instead of following the recommended schedule. Additionally, the patient did not experience any side effects. Furthermore, it was reported that prescribing physician was notified about the same. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient was administered the first 2 doses of Vivotif consecutively (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient was administered the first 2 doses of Vivotif consecutively (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.
Post vax, the pt developed headache, fever, swollen lymph nodes behind ears, and patch of red bumps on left arm.
Initial report received from a healthcare professional on 16 OCTOBER 2014. This case is lined to the case 2014SA157396 and 2014SA157397. A female patient, whose medical history and concomitant medications was not reported, had received an intramuscular 0.5 ml dose of FLUZONE QIV (batch number UI190AC and expiry date 16-JUN-2015, site of vaccination not reported), on an unspecified date. On an unspecified date, after vaccination the patient had large injection site swelling, greater than 2 inches. They have redness and itching immediately after injection. The patient also presented with 10 inch welt on her thigh and had a low grade fever. The patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. The child was positive for strep and is receiving antibiotics. The patient required ER visit. At the time of this report the outcome was unknown. List of documents held by sender: none. Follow up information received from Physician on 14 JANUARY 2015.  A 5 year old female patient had developed elevated boy temperature of 100.4 several hours after receiving FLUZONE QIV on 13 OCTOBER 2014. On 14 OCTOBER 2014, patient developed swelling and redness at the site of injection (area of erythema was: 8 inches x 10 inches). The lesion rapidly increased in size and the patient was seen on 15 OCTOBER 2014. It was also reported that prior to 4 weeks no vaccine was administered. The patient had no illness at the time of vaccination, no pre-existing diagnosed seasonal allergies and birth defect, medical condition. The details of laboratory investigations included the rapid strep test was positive on an unspecified date and CBC done on 17 OCTOBER 2014. The corrective treatment included Augmentin (dose: 600 mg, frequency: twice a day). At the time of this report, the patient was recovered from the event of swelling and redness on 17 OCTOBER 2014, while outcome for low grade fever was unknown. Note: The available source document was in handwritten format hence document is not legible. Addendum: 05-MARCH-2015. Upon second medical examination of case at time of internal review the following has been modified in this case. Significant correction was done to correct the product code from 450 to 477.
Multiple lung nodules were seen on CT of Abd/Pelvia done on 11/28/2022 (previous Abd/Pelvis CT did not show in 4/2022).  Follow-up chest CT showed nodules ccoalesced into larger mass.  PET scan 12/19/2022 showed "Intensely hypermetabolic innumerable lung lesions that demonstrate rapid interval growth and formation of new foci, involving the parenchyma and pleura, as well as lesions in the left neck, thoracic and left axilla."  Diagnosed by bronchoscopy 12/26/2022 as Diffuse large B Cell lymphoma.  Patient started having fevers and was initiall admitted to hospital from 1/6/23-1/10/23.  Was then admitted to hospital 1/16/2023 and expired 2/25/2023 after many complications and one failed chemotherapy treatment. Patient expired 2/25/2023. Patient had initial series of Pfizer-BioNTech COVID 19 vaccine on 1/20/21 & 2/1/2021 with booster 10/19/2021 and bivalent vaccine booster 9/12/2022.   He was in good health with no infection of COVID prior to findings on CT 11/28/2022.  Was the lymphoma caused by or exacerbated by COVID and/or Flu Vaccine?
The pt experienced fatigue, runny nose, sore throat and no temp. The pt also experienced swelling of the left eye with discoloration. The next day the pt experienced swelling under both eyes, lips slightly swollen, Treated with Benadryl.
2nd dose of Moderna given at 10:00am; felt tired a few hours later. Around 8:45pm, same day, began with non-stop chills, aches & elevated fever (under100) lasting approximately 9-10 hours. Fever was 100.2 degrees next morning. Chills subsided but aches continued another 24 hours. Used max amount of Tylenol throughout this time and for another 2-3 days. Very tired if any activity was attempted such as walking in house or trying to cook, etc.  After 3-4 days felt better but a rash developed on insides of both arms that also itched. This lasted a few days, was helped a little with Benadryl oral and cream applied to rash but it went away without further medical attention.
Swelling of glands in right armpit to the size of a baseball, soreness in shoulder neck and back, small lump at injection site.
EXTREME FATIGUE;  CHILLS;  EXTREME HIGH HEARTBEAT FOR APPROX 15 OR SO HOURS (So extreme I honestly thought I might have a heart attack or stroke).    And the suddenly after many hours all the above symptoms stopped and I felt fine.
Head dropping spells started within 8 hours of vaccines; frequency of spells decreased over next 48 hours and resolved.
feels a little nausea; headaches; A spontaneous report was received from a healthcare professional concerning a 83-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headaches, feels a little nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the event(s) headaches,On 5 Feb 2021, the patient experienced the event(s) feels a little nausea.  Treatment details included She has been taking Tylenol for the headaches, but it doesn't seem to be doing too much..  Action taken with mRNA-1273 in response to the events was not reported.  On 6 Feb 2021 the outcome of event(s), feels a little nausea was resolved. The outcome of event(s), headaches was unknown.
Information was received from a nurse concerning a third grade student who on 25 SEP 1996 was vaccinated with a dose of Varicella.  On 20 DEC 2004 the student developed chickenpox.  According to the school nurse there were 58 other elementary school students and 34 of them had previously been vaccinated with a dose of Varicella.  Unspecified medical attention was sought.  There was no information regarding the present status of the student.  No product quality complaint was involved.  Additional information was requested.
BioNTech Covid-19 Vaccine  I experienced sudden severe chills lasting 2-3 minutes. I also had extreme elevation of pain to my injured knee from a 5 to 10+ during this episode. The chills resolved spontaneously.
Sore arm where injectionwas given.; Itching in the injection sight; Itching in neck, cheststomach back and other partsof the body.; Red blotches in the core areas.; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in left arm on 13Mar2021 at 07:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included sinus issues with sinus surgery in 2004, glute or hamstring surgeries in Oct2020. It was reported that the patient was an extremely active slim person and the glute or hamstring surgeries were healed for the most part. In Nov2020, the patient had COVID-19. The patient was tested positive for COVID-19 antibodies in Dec2020. Patient used to get the reaction at times when she gets a virus or bacterial infection for a day. Concomitant medications included diclofenac sodium (MANUFACTURER UNKNOWN), SUDAFED and supplements on unknown dates and for unknown indications. Prior to the vaccination the patient had not tested positive for COVID-19 and since the vaccination, the patient had not been tested positive for COVID-19. It is unknown if patient has allergies to food, medications or other products. On 14Mar2021, one day after vaccination, at 15:00, the patient experienced sore arm where injection was given, itching occurred in many different places such as the injection sight, neck, chest stomach back and at times other parts of the body. The patient also experienced red blotches in the core areas. The patient did not receive any treatment for the events.The clinical outcome of sore arm where injection was given, itching at the injection sight, itching on neck, chest stomach back and at times other parts of the body and red blotches were not recovered.    No follow-up attempts are needed. No further information is expected.