chrisvoncsefalvay/vaers-outcomes huggingface dataset:
angioedema of the feet, hands & lips, nose & eyes & non-pruritic rash x 1wk p/vax;nothing @ inj site;tx w/DPH & solumedrol;last dose of vax 6SEP84;
Post nasal drip, headaches, chills, hot flashes, and red raised bumps that are raised
pt recv vax 4APR95 & exp severe swelling @ the inj site;the area which was 3 inches by 5 inches, became infected;also exp t104 & was treated w/ATB;no further details were provided;
my heart began to pound in my chest, beat out of rhythm, race/tachycardia; my heart began to pound in my chest, beat out of rhythm, race/tachycardia; my heart began to pound in my chest, beat out of rhythm, race/tachycardia; Dizziness; nausea; shortness of breath; fingers and toes went tingly and cold; fingers and toes went tingly and cold; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 39-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0198, Expiry date: unknown, at the age of 39-year-old), dose 1 via an unspecified route of administration, administered in Arm Left on 10Jul2021 03:00 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication. The patient previously took fentanyl for drug hypersensitivity and experienced drug hypersensitivity (known allergies: Fentanyl). No covid prior to vaccination or tested covid post vaccination. Patient did not receive any other vaccine in four weeks. The patient reported that within 2 min of vaccination my heart began to pound in my chest, beat out of rhythm, race/tachycardia on 10Jul2021 15:15. The patient experienced dizziness, nausea, shortness of breath. on 10Jul2021. The patient reported that her fingers and toes went tingly and cold on 10Jul2021. Patient sat for 30 plus minutes trying to regulate my breathing pattern and prevent passing out. Patient remained seated as instructed by the pharmacist. The event arrhythmia was reported as medically significant. It was reported that patient did not receive any treatment. The clinical outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.
I woke up the next morning (about 6am) with nausea/chills/fever (100.9)/headache/eyes were burning. I had to go to ED after getting to work(at 7:30am) due to SOB/elevated heart rate of 145-150bpm/101.6 temp (upon arrival to ED)/chills/nausea/headache. I was given IV fluids (2 liters), Zofran for nausea, Toradol for pain/headache, Tylenol for fever. I was in the ED for about 4-4 1/2 hours. My right eye has a large "blood shot" area that wasn't there until I took the vaccine also. I was found to still have a count of "34" on my Covid antibody blood test. The ED physician stated that was probably the reason I had the reaction was because I still had antibodies. I tested positive for Covid on Sept 19, 2020 and took the vaccine #1 1/11/2021 (almost 120 days from positive Covid test). If I had known I was going to have any type of reaction because I still had antibodies, I would have waited a few more weeks/months to get the vaccine. This should really be looked into. I am now very scared to receive the 2nd vaccine because of the side effects that has been reported after the 2nd vaccine. I really need good advice about what to do about 2nd vaccine.
Swelling under the eyes and rash on the cheek bones. Likely exacerbation of prior rash after a hot shower. Improved with Zyrtec and diphenhydramine. Patient has history of eczema and asthma.
28AUG96 mom states pt had sore arm & high pitched cry;fever but didn't take temp;also says pt has poor appetite;18SEP96 mom states the crying lasted 9 days & pediatrician says the pt has viral infections in both ears & doubts r/t vax
Stroke on 4/19/21, less than 2 weeks after second Modern?s covid dose.  Vaccine received.  Stroke happened  and initially treated at Medical  center.  After 25 days in the hospital, patient was transferred to in patient rehab, another hospital stay for blood clots, and out patient rehab.
Temperature excursion of the vaccine with no reported adverse event; medication error due to product being administered post excursion with no reported adverse events; Initial information received on 11-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] post temperature excursion with no reported adverse events.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included hepatitis B vaccine.  On an unknown date the suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine was exposed to a temperature excursion with no reported adverse event (product storage error).  On 06-Jul-2022, the patient received 0.5 mL dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine Injection (lot UJ668AA; expiry date: 13-May-2023) via intramuscular route in the left thigh for prophylactic immunization.  On 06-Jul-2022, the patient was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] post temperature excursion with no reported adverse events (poor quality product administered) (latency: same day).  Action taken was not applicable.  Outcome: Unknown for both the events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
OCCASIONALLY LIGHT PSORIASIS FLARES; COVID; COVID-19; AFTER VACCINE SUFFERED SYMPTOMS; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), IMMUNISATION REACTION (AFTER VACCINE SUFFERED SYMPTOMS), PSORIASIS (OCCASIONALLY LIGHT PSORIASIS FLARES) and COVID-19 (COVID) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In October 2020, the patient experienced COVID-19 (COVID-19) and IMMUNISATION REACTION (AFTER VACCINE SUFFERED SYMPTOMS). In 2021, the patient experienced COVID-19 (COVID). On an unknown date, the patient experienced PSORIASIS (OCCASIONALLY LIGHT PSORIASIS FLARES). At the time of the report, COVID-19 (COVID-19) and COVID-19 (COVID) had resolved, IMMUNISATION REACTION (AFTER VACCINE SUFFERED SYMPTOMS) outcome was unknown and PSORIASIS (OCCASIONALLY LIGHT PSORIASIS FLARES) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication information was  provided.  It was reported that In October 2020, the patient experienced Covid and after vaccine suffered symptoms. The patient had occasional light psoriasis flare that last only for a day or so. Patient had covid in Oct 2020 and  had these symptoms after each vaccination.    It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication information was provided.
Patient presented to the hospital with extreme weakness and shortness of breath. Admitted for Covid-19 infection with pneumonia and acute respiratory failure. Treated with steroids, remdesivir, oxygen supplement. Patient remained on high-flow oxygen and BiPaP. Went into afib with RVR, amiodarone drip started. Patient was emergently intubated. Post-intubation xray showed bilateral tension pneumothorax, chest tube was placed. Later in the night, patient had a cardiac arrest. ROSC was achieved but patient suffered another cardiac arrest. ROSC was not able to be achieved and patient passed away.
Itchy  rash on injection arm, size of a hand.  Appeared 8 days after vaccination   Pregnant, due date December 2021
Patient reported throat itching ~30 minutes post-vaccination. Given cetirizine 10 mg orally x 1 dose. Itching/burning spread to oral mucosa (throat, roof of mouth), denies other symptoms. Given epinephrine 0.3 mg IM x 1, IV line started w/ NS at 125 mL/hour, diphenhydramine 50 mg IV x 1 dose all 5 minutes after cetirizine. EMS called, patient transported to ED for further evaluation.
Information has been received from a health care professional concerning a 26 year old postpartum female with a hx of rubella as a child and a negative rubella titer on 6/23/1998 who on 2/2/99 was vaccinated with one dose of rubella vax. On the evening of 2/14/99, the pt experienced a blistering, painful rash at her fingertips with dry itchy skin. By 2/19/99, the rash had "progressively spread to her elbows and on her lower legs to her knees." No further information is available.
MILD HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On an unspecified date, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild headache was not reported. This report was non-serious.
It was reported that a male patient received a Fluzone vaccination during Oct 1999. Approximately one month later the patient developed "flu-like" symptoms, feeling in his head like a head cold persisted. The patient has been seen by an Allergist and also has had an MRI. The MRI results were not provided.
I felt a lump on the right interior part of the neck about 2 cm, I had an ultrasound, CAT scan, and removal of 2 lymph nodes. I was diagnosed with swollen lymph nodes and follicular lymphoma. I had scheduled a biopsy and a CAT scan confirmed the two lymph nodes and PET scan showed an enhancement in the rectum and sacrum. I have recovered from the surgery but not from the adverse event since I was diagnosed with cancer (Follicular lymphoma) and I am still under evaluation to see if it is stage 4.
1/2 of face began swelling after receiving Prevnar vaccine. Swelling occurred on same side as shot was given. Most noticeable in cheek and eyelid and ear.
Facial selling.  Started in chin area where I had facial filler and then spread over face and neck overnight.  Woke up with hives on torso, back, butt and inner thighs.
Patient (associate of store) received Pnemovax 23 vaccination on right arm IM on 6/3/16. On 6/5/16 patient came in the pharmacy reporting redness, warm and tenderness on upper right arm with minor swelling starting the night after the injection. No other sympotms in other areas of body. Patient was advised to monitor swelling and pain and redness. He was instructed to use ice packets / cold compress and he is taking ibuprofen for pain. Patient was explained to that this is a mild reaction and his symptoms will be reported. HE was asked to monitor his symptoms and report any symptoms worsens or contact dr if any more severe reaction occurs. Reaction is also reported to VAERS.
This spontaneous report as received from a registered nurse (other health professional) refers to two patient of unknown age. Pertinent medical history and concomitant medications were not reported.    On 27-OCT-2016, the patient was vaccinated with M-M-R II lot # M007279, expiry date 09-FEB-2018, for prophylaxis which were improperly stored (incorrect product storage) temperature/ time: 35.6 F for 24 hours and call was not because of data logger. Previous temperature excursion was 59.4F for 1 hour and AE was administered. The outcome of incorrect product storage is unknown. The reporter considered incorrect product storage to be not related to M-M-R II. No adverse effects were reported. No further information provided. This is one of two reports from same reporter. MARRS # 1701USA003812.  Additional information is not expected as the reporter did not give us consent to contact physician
Patient developed tingling in her hands and feet the same evening as the vaccination. She also developed vertigo and fatigue. She has some muscle cramping in her legs. The vertigo is affecting her daily life.
Syringe broke during administration; This spontaneous case was reported by a pharmacist and describes the occurrence of SYRINGE ISSUE (Syringe broke during administration) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced SYRINGE ISSUE (Syringe broke during administration). On 17-Jun-2021, SYRINGE ISSUE (Syringe broke during administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable
Injection site is warm to touch and reddeded, area is 6" X 3". Patient applied ice and took ibuprofen.
soreness & swelling from elbow to shoulder w/in 4 hrs p/inject;arm felt hot to touch & hard;could not stand to be touched; same area of arm was red by next day w/a lump on inside of arm; itching & soreness across base of neck lt knee & lt ;
Throat Tightness, tingling in fingers/Toes, Flushing/ Sweating, headache, itching, Lightheadedness--gave 2 BENADRYL, water, monitored. Checked blood pressure pulse (135/85, 65) monitored for 30 minutes. Patient left was advised to continue BENADRYL every 4 hours. Called and checked on patient 1 day post reaction---just soreness at injection site.
just feeling weird; Tingling in the legs; bouts of dizziness; tired; arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 (Lot number: EW0167) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "HPV" (ongoing). Family history included: "Heart disease" (unspecified if ongoing); "diabetes" (unspecified if ongoing), notes: family who had breast, colon and liver. The patient's concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset 10May2021, outcome "not recovered", described as "Tingling in the legs"; PAIN IN EXTREMITY (non-serious) with onset 28Apr2021, outcome "recovered" (01May2021), described as "arm pain"; DIZZINESS (non-serious) with onset 03May2021, outcome "not recovered", described as "bouts of dizziness"; FATIGUE (non-serious) with onset 29Apr2021, outcome "recovered" (03May2021), described as "tired"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "just feeling weird".  Additional information: Tingling in the legs was worsened. The patient stated that she was diagnosed with HPV at 17 she stated that she went through treatments and has carried on through. She stated that she just went through some pap smears and her doctor had said they got rid of it. She stated she did not have heart disease and diabetes but was does run in her family. She did have two procedures to remove precancerous cells in 2015 from the HPV. The patient stated she was a massage therapist, and she said her arm was sore, but she was able to work through it. She stated that she was feeling bouts of dizziness off and on over past few weeks. The tingling, like pins and needles, started happening last night and persisted into today. She stated that her legs felt like they are falling asleep, and this was happened 13 days afterward. The patient did not visit the emergency room or physician office for the events.  No follow-up attempts are possible. No further information is expected.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 27-Mar-2021 at 9:39 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:39 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 27.70.  Concomitant products were not provided.  On 27-Mar-2021, Excursion time was 09 AM and 10 AM, temperature was 35 and 35, total doses given for the day was 195, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies as provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of VARIVAX injection, subcutaneously, lot # L050560 with expiry date 14-DEC-2017 and lot # L010146 with expiry date 24-MAR-2016 (dose and anatomical location were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
While administering the vaccine, it was noted that the vaccine was leaking out of the hub of the syringe.  The syringe was withdrawn and it was determined that none of the vaccine had made it to the needle of the syringe. RN, BSN, MS, MD were notified and ordered the vaccine dose to be repeated in the patient's opposite arm (his right), and observe him for 30 minutes for any reactions.  There were no reactions noted.
unbearable pain at the injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   On 5th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site pain. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the Pharmacy Intern. The pharmacy intern stated that the patient experienced unbearable pain at the injection site for the first 2 to 3 days after injection even after taking Alleve.  At the time of the reporting, the patient had pain on the scale of 2 out of 10.  No further details were provided.
Pt explained that her arm was sore on Saturday and a little red, but nothing too bad she thought it was normal. Then on Saturday evening into Sunday morning her arm had swollen up to 3 times its size and she couldn't lift it above her head without pain. Pt continued to work it so she could go to work. It was red and hot too. Pt did not take any medication and was aware of this possibility because she has been sensitive to medications her whole life. Now her arm is normal size and just a little warm and pink, but she believes the reaction is mostly over.
Covid/Moderna arm - Arm swelled up the size of a football. Red, itchy, hot to the touch. Overall fatigue and small fever.
Redness and swelling at injection site 3" in diameter. Slight Pain (scale of 1-10) 3 No treatment.