chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flares ups; face gets a little puffy; swollen; welts; a lot of cosmetics; lips get cracked; This is a spontaneous report from a  sponsored program . A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as UNKNOWN, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that "she has an allergy to gallates (cant really spell it) something like propyl gallates and like doxyoxy. not really sure, it's like a bunch of gallates they put in preservatives, propeloxidal, like oxyitol?? doxyotol. Patient has seen a list of ingredients, what was says is it that like if you are allergic to PEG, propylene gallates and all that do not get the Pfizer vaccine, the CDC has that list do not get the vaccine if you are allergic to what I am allergic to". Patient Stated that, she has been to a few HCP and no one would tell her not to get it no one would tell her to get it. On an unspecified date, she not had severe reactions but gets flares ups all the time, like an internal, lips get cracked and puffed, face gets a little puffy, swollen sometimes and had welts, usually from a lot of cosmetics and it could be food but over the past year, year and a half has been having a lot more flare ups, so when she has gone to the doctors she said maybe in some of her food it was effecting her a little more. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
ACHY, PAIN AT SITE, LETHARGY, TEMP, CHILLS
redness on upper right arm; red (blotchy looking); mild itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (mild itching), RASH MACULAR (red (blotchy looking)) and ERYTHEMA (redness on upper right arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, TRAMADOL, OMEPRAZOLE, LORATADINE (CLARITIN [LORATADINE]) and METOPROLOL for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PRURITUS (mild itching). On 11-Mar-2021, the patient experienced RASH MACULAR (red (blotchy looking)). On 18-Mar-2021, the patient experienced ERYTHEMA (redness on upper right arm). At the time of the report, PRURITUS (mild itching), RASH MACULAR (red (blotchy looking)) and ERYTHEMA (redness on upper right arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided
25 mins p/vax pt devel urticarial rash scattered over entire body; DPH given; parent informed that pt needs allergy testing prior to any further DTP/HIB immun;
Pt recvd routine initial battery of vaxs for recruits; on 12NOV93 devel leg weakness which quickly progressed to point of being unable to stand; arms also became weakened; was hosp & plasmapheresed; condition improved greatly; dx: GBS;
Patient is here today for COVID-19 immunization per federal guidelines/written order. See immunization activity for details. Patient was observed post-immunization for a minimum of 30 minutes due to previous history of immediate allergic reaction to a vaccine or injectable therapy and/or history of anaphylaxiswith evidence of throat tightness and itching.  Anaphylaxis Management Standing Order protocol initiated.  Physician/APP notified of patient condition.   Additional orders received: per Doctor:  Benadryl 50 mg IM x one.  COVID-19 (MRNA) VACCINE Allergen added to patient's Allergies. VAERS reporting completed as appropriate. .   1400:  At end of 30 minute observation period (due to hx of latex allergy), patient complained of itching on chest and throat with some 'tightness' in her throat.  Patient escorted to exam room and met with RN and the doctor. 1405:  Benadryl 50 mg IM given right deltoid per order of the doctor who examined and talked with patient.  Will monitor additional 30 minutes post injection per MD order. 1412: BP 120/64, P 61, Pulse Ox 100% on room air. 1414: Patient states she can now swallow with ease.   1418:  Patient states swallowing is good and itching is subsiding. 1425: Patient states feeling much better, just sleepy (spouse is driving her home). 1432:  Redness on chest gone, patient states itching has resolved and throat is open.  Breathing unlabored with no additional symptoms.  Discharged ambulatory to meet husband downstairs who will drive her home.     Per direction of Doctor, patient will premedicate with oral Benadryl prior to receiving 2nd COVID vaccine.  Patient verbalizes understanding.     COVID-19 post-vaccination Patient Instructions added to After Visit Summary for patient to review.
vaccine site soreness very thirsty chills body aches diarrhea fever 101.4 acid burning feeling in stomach
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On an unspecified dates in 2012, the patient was vaccinated with the first and the second (0.5 ml each) dose of GARDASIL (route of administration, lot number and expiration dates were not reported). On the day of the report (26-SEP-2016), the patient visited the physician's office to receive the 3rd dose of GARDASIL. Additional information has been requested.
Patient came in for a Pfizer covid vaccine booster today and also received Flucelvax vaccine. The order was reviewed by precepting pharmacist, and vaccines were administered by intern. The patient was then sitting in the observation area when she started feeling weak and then started to lose consciousness. The mother quickly alerted the pharmacy staff and we rushed to assist patient. We paged code white over the intercom to alert management of the situation. We placed an ice pack behind patient's neck and the patient immediately regained consciousness. We also provided them with some snacks and cold water in case the patient was feeling low on sugar. We took a blood pressure reading and the patient had a BP of 84/48 which could explain the syncopy. Market manager was immediately. Reassessed patient after 30 minutes and the blood pressure is now 97/84. The patient is alert and oriented to everything happening. The mother will drive patient home and will alert the pharmacy if anything else occurs.
Severe pain upper abdomen left side below armpit - armpit swollen as well. Below arm pit on rib cage swollen size of baseball swelling hurts to the touch and at rest.
erythema multiforme w/diffuse target lesions, hives;lower extremity mottled & violaceous w/coolescene of wheals;rx pred;
Heart palpitations/atrial arrhythmia and chest discomfort.  Still ongoing after eight months.
Left arm with large, warm, area of swelling extending from site of injection distally to a few centimeters below elbow. Edges serpentigious minimally tender, no other rashes.
Hives within 8 hours of administration of Hep A went to facility that night - treated as hives - gave Epipen didn't use Benadryl came to doctor's office 8/23/07 because hive were worse - treated with Zyrtec 5mg BID and 2mL Epinephrine SQ.
Multiple Pulmonary Emboli on both sides of the lungs\  multiple Pulmonary emboli like a spray of blood clots in the lungs; had trouble breathing; sharp pain on the right side of the chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Multiple Pulmonary Emboli on both sides of the lungs\  multiple Pulmonary emboli like a spray of blood clots in the lungs), DYSPNOEA (had trouble breathing) and CHEST PAIN (sharp pain on the right side of the chest) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 007C21A) for COVID-19 vaccination.     The patient's medical history was not provided.  Concomitant products included SIMVASTATIN for an unknown indication.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PULMONARY EMBOLISM (Multiple Pulmonary Emboli on both sides of the lungs\  multiple Pulmonary emboli like a spray of blood clots in the lungs) (seriousness criteria hospitalization and medically significant), DYSPNOEA (had trouble breathing) (seriousness criterion hospitalization) and CHEST PAIN (sharp pain on the right side of the chest) (seriousness criterion hospitalization). The patient was hospitalized from 20-Apr-2021 to 21-Apr-2021 due to CHEST PAIN, DYSPNOEA and PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Multiple Pulmonary Emboli on both sides of the lungs\  multiple Pulmonary emboli like a spray of blood clots in the lungs), DYSPNOEA (had trouble breathing) and CHEST PAIN (sharp pain on the right side of the chest) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Computerised tomogram: multiple pulmonary emboli CT scan showed multiple Pulmonary emboli like a spray of blood clots.         Patient was taken to emergency room (ER) on 20-APR-2021. Patient was discharged next day given prescription of blood thinners and pain medications.  Action taken with mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Receive the first dose ov vaccine at about 8am on 12/30/2020, at about 4pm, started to feel not well, pain in the yes, weakness,  upset stomach and nausea, without vomiting.  Checked temperature, it was 98.7f, then the condition was worsening,  bad body aches and temperature went up to 99.5, 100.5, 101, and 102. Very bad body aches , weakness,  nausea,  temperature up to 102 on 12/30/2020 evening at 9pm. That is whe i took Terraflu and ibuprofen.  The temperature still for about 3 hours was high,  100.9, then went dawn to 99.6 and I went to sleep. Woke up at 3am, feel bad,, body aches and temperature is up to 100.3 at 5am on 12/31/2020. Taking terraflu again.
I have had pain in the exact spot of my flu shot since I received it on 11/4/2019. Within a few day I had lost my range of motion and physical strength. I felt like my arm was dead weight. I couldn't pull up my pants, move my arm above my head or carry a gallon of milk. I messaged my Dr who recommended warm compresses. The pain got worse and I made an appt to see my Dr. who recommended physical therapy. After 5 appts and 6 weeks later - I had regained my range of motion but could not get rid of the pain. I went back to the Dr who recommended an MRI and completing physical therapy. I have 2 more appts left. I continue to have pain in any direction I move my arm. I feel it all night and it constantly aches. I don't know if I will have permanent damage at this point. I have lost physical strength in my left arm and it affects my daily life all day long.
Juvenile Arthritis: started mid-June 2005 with fever 101.5 to 103 every evenings (never the morning) until July, then joint pains (hip, shoulder, fingers, neck) in August 2005 that conducted her to the emergency room on 08-15-2005 since she could hardly move. Treated with Naproxen from 09-02-2005 to 10-10-2005, prednisolone since 10-10-2005, and methotrexate since 12-08-2005.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a child subject of unspecified gender who was vaccinated with KINRIX, (GlaxoSmithKline). In July 2014, the subject received an unspecified dose of KINRIX (unknown route and injection site, batch number not provided). In July 2014, less than 2 weeks after vaccination with KINRIX, the subject experienced swelling injection site. This case was associated to a product complaint. The subject was treated with BENADRYL. At the time of reporting, the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with KINRIX. The reporter reported 2 other cases of swelling injection site after vaccination with KINRIX (cases A1083480A and A1083483A). These cases were associated to a product complaint since the reporter said that these cases happened in a relatively short period of time so she was afraid they were related to a specific lot of the vaccine. Follow-up information received on 11 August 2014: A safety statement was requested, an evaluation was performed and the conclusion shows that: "The review of the currently available safety data for batch number 94F5K and family does not highlight a safety issue. It is unlikely that the reported events are related to a manufacturing problem. No investigation required."  GlaxoSmithKline Biologicals considers this product complaint as unsubstantiated.
35 patients received a 0.25 ml dose as booster from booster dose only presentation vial; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial).    No concomitant product use was reported.   Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022.  It was unknown if patient experienced any symptoms after getting the vaccine.  Treatment information was unknown.
1/2/21 @ 1030:  EE called to report she received the vaccine on 12/31/20 between 1030 and 1100.  And then around 2330 on 12/31/20 she experienced facial swelling, arm swelling, headache, chills, and dizziness.  EE stated she felt it was an allergic reaction to the vaccine and took Benadryl for the next 24 hours to help with the symptoms.  EE reported she hasn't had anything since the initial 24 hours, but is concerned about taking the next vaccine.  Encouraged EE to contact PCP regarding concern for taking next vaccine.  After speaking with Administration, EE encouraged to report vaccine side effects to CDC via V-Safe (https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html).
vaccination site inflammation; vaccination site swelling; vaccination site red mark; Illness; Flu like symtpoms; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Illness), INFLUENZA LIKE ILLNESS (Flu like symtpoms), VACCINATION SITE INFLAMMATION (vaccination site inflammation), VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE ERYTHEMA (vaccination site red mark) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced ILLNESS (Illness) and INFLUENZA LIKE ILLNESS (Flu like symtpoms). On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (vaccination site inflammation), VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE ERYTHEMA (vaccination site red mark). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (Illness), INFLUENZA LIKE ILLNESS (Flu like symtpoms), VACCINATION SITE INFLAMMATION (vaccination site inflammation), VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE ERYTHEMA (vaccination site red mark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.    This case was linked to MOD-2021-032397 (Patient Link).
Information has been received from a health professional through a Merck pregnancy registry concerning a 17 year old female with no known allergies who on 15-SEP-2006 was vaccinated intramuscularly in the right deltoid with the first dose of Gardasil (Lot#653735/0688F). Concomitant therapy included hormonal contraceptives (unspecified). On 11-OCT-2006 the patient had a positive urine pregnancy test. It was reported that the patient had previously had a negative serum pregnancy test on 17-JUL-2006. The patients last menstrual period was on 15-AUG-2006. The patient sought unspecified medical attention. At the time of this report the outcome of the event was unknown. Follow up information was received from a registered nurse stating that on an unspecified date prior to delivery the patient developed an increased white blood cell count (actual values not provided) and was diagnosed with suspected occult chorioamnionitis. The nurse did not know if the patient received any treatment for the condition, if any other testing was done, or when and what the results of follow up white blood cell count were. The nurse also reported that on 04-JUN-2007 the patient delivered a normal healthy baby girl with no congenital anomalies by cesarean section. The nurse reported that the reason for the cesarean section was "unrelieved pain". The mother and baby were both discharged on 11-JUN-2007. The nurse did not know the reason for the extended hospitalization. Additional information has been requested.
Appendicitis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criteria hospitalization and medically significant). At the time of the report, APPENDICITIS (Appendicitis) outcome was unknown.            Concomitant medication not reported.  Treatment medication not reported.  Patient reported that her 4 siblings who had the Moderna COVID-19 vaccine also ended up with appendicitis after second vaccine.  This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected event of appendicitis. The event occurred on the same year as the received second dose. The rechallenge is not applicable since no information about the first dose was provided.The benefit-risk relationship of the vaccine is not affected by this report   This case was linked to MOD-2021-374939, MOD-2021-373492 (Patient Link).; Sender's Comments: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected event of appendicitis. The event occurred on the same year as the received second dose. The rechallenge is not applicable since no information about the first dose was provided.The benefit-risk relationship of the vaccine is not affected by this report
03/06//2021:  Seen in ER for severe headache. BP checked and was good.  Covid test = Neg.  Labs drawn and shows low plt count.  MRI showed lesions/clots on brain.  test for Lupus = Neg.  Hep panel = Neg. Admitted to hospital for 17 days.  Treatment with plasmapheresis, rituximab and steroids.
Dose #2 of Moderna given 6 days prior to due date 1st Moderna Vaccine given (1/15/2021)
Patient presented to the ED on 4/28/2021for COPD exacerbation. Patient presented to the ED on 5/11/2021 and was subsequently hospitalized for 3 days. These visits are within 6 weeks of receiving COVID vaccination.
Extremely painful right shoulder in the area of injection sites, then expanding to arm 4 hours after receiving shots. Skin redness developed the next day, including some swelling. Within 8 hours I had a low grade fever, severe chills and shivering, and my are could not move without severe pain. The shoulder and arm pain and lack of mobility lasted for 4 days until taking prednisone.
Within 15 minutes raised red spots appeared primarily in torso (same on arms, neck and legs) severe itching. This lasted 3-4 hours.
PATIENT WAS NOT NERVOUS ABOUT RECEIVING HIS FIRST DOSE. OUR IMMUNIZATION CERTIFIED PHARMACY TECH ADMINISTERED THE DOSE. ABOUT 2 MINUTES LATER HE STATED HE WAS FEELING TINGLY AND HIS EAR TURNED A WHITE COLOR. THE TECHNICIAN CALLED ME INTO THE ROOM WHERE I EXAMINED THE PATIENT. HE WAS NOT RESPONDING AND HIS EYES WERE DILATED. HE WAS TRYING TO BREATH BUT HE WAS HAVING DIFFICULTY. WE MOVED HIM TO THE GROUND AND PLACED HIM ON HIS SIDE TO MAKE SURE HE DID NOT ASPERATE. AFTER ABOUT 20 SECONDS OF BEING ON THE GROUD HE STARTED BREATHING NORMALLY AND WAS CONSCIOUS. THE ENTIRE EPISODE LASTED ABOUT 1 MINUTE (MAYBE SLIGHLY LONGER). EMS ARRIVED A FEW MINUTES LATER. HIS PULSE WAS LOW (ABOUT 50 BPM PER EMS) BUT HIS BLOOD PRESSURE WAS NORMAL (UNSURE OF THE VALUE). HE SAID HE REMEMBERED TALKING TO US AND THE NEXT THING HE KNEW HE WAS LAYING ON THE GROUND. HE WAS VERY NAUSEOUS AFTERWARDS FOR ABOUT 45 MINUTES (HE THREW UP TWICE). WE CONTACTED THE PATIENT THE DAY AFTER AND HE SAID HE WAS FINE AND THAT HE ONLY HAD A SORE ARM. WE BELIEVE THAT HIS BLOOD PRESSURE DROPPED TOO LOW AND CAUSED A VASOVAGAL TYPE RESPONSE.
Patient was administered Kinrix vaccine at 7mths, when it should only be administered for children 4-6 years old. Patient had no adverse reaction. Patient was referred to administering facility for just this one vaccination, then returned back to PCP. PCP and patient's mother are both aware.