chrisvoncsefalvay/vaers-outcomes huggingface dataset:
symptoms consistent with anaphylaxis; This is a literature report. A health-care system experience. The full publication has been requested. This author reported different events for five patients. This is the first of five reports.  A subject of unspecified age and gender received bnt162b2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications were not reported. The subject experienced symptoms consistent with anaphylaxis on an unspecified date with outcome of unknown. The subject underwent lab tests and procedures which included allergy test with unknown results.  Background: Adverse reactions, including anaphylaxis, to messenger RNA coronavirus disease 2019 (COVID-19) vaccines rarely occur. Because of the need to administer a timely second dose in subjects who reported a reaction to their first dose, a panel of health-care professionals developed a safe triage of the employees and health care providers (EHCP) at a large health-care system to consider administration of future dosing. Methods: There were 28,544 EHCPs who received their first dose of COVID-19 vaccines between December 15, 2020, and March 8, 2021. The HCPs self-reported adverse reactions to a regulatory authority. A regulatory authority screened and collected information on the quality of reaction, symptoms, and timing of the onset of the reaction. Results: Of 1253 calls to a regulatory authority, 113 were identified as requiring consideration by a panel of three-certified allergists for future dosing or formal in-person assessment. Of the 113 EHCPs, 94 (83.2%) were recommended to get their second dose. Eighty of 94 received their second planned dose without a severe or immediate reaction. Of the 14 of 113 identified as needing further evaluation, 6 were evaluated by a physician and subsequently received their second dose without a serious adverse reaction. Eight of 14 did not receive their second dose. Only 5 of the 113 HCPs reported reactions (4.4%) were recommended to not take the second dose: 3 (2.6%) because of symptoms consistent with anaphylaxis, and 2 because of neurologic complications (seizure, stroke). Conclusion: The panel demonstrated that, by consideration of reaction history alone, the HCPs could be appropriately triaged to receive scheduled second dosing of COVID-19 vaccines without delays for in-person evaluation and allergy testing.; Sender's Comments: A contributory role of BNT162B2 in triggering the onset of Anaphylaxis cannot be fully excluded, considering the temporal relationship and known adverse event profile of the suspect vaccine,Linked Report(s) : US-PFIZER INC-202101300161 Same article/drug; Different patient/event;US-PFIZER INC-202101300162 Same article/drug; Different patient/event;US-PFIZER INC-202101301646 Same article/drug/event; Different patient;US-PFIZER INC-202101301645 Same article/drug/event; Different patient
During the 10 minutes into the 15 minutes observation period patient reported feel heavy pressure of her chest, slight difficulty swallowing and dizziness. BP 118/78, HR 73, O2 Sat 98%.  Patient was observed for another 30 minutes and reported feeling better, denies any of the previous symptoms. Another set of vitals was obtain BP 110/62, HR 62, O2 sat 98% and patient was discharged home and instructed to follow up with her PCP.
Information has been received from a physician assistant concerning a 48 year old female with common variable immunodeficiency and sulfonamide allergy and a history of pneumonitis referred to as "BOOP" who on 06-MAY-2008 was vaccinated with her first dose of PNEUMOVAX (lot number 658673/0990U) IM into her right deltoid. Concomitant therapy included albuterol inhaler. On 06-MAY-2008 2 hours after vaccination the patient developed malaise, scratchy throat and flushed cheeks. Later that night, the patient experienced soreness at the injection site, increased malaise, fever of 102.4F and chills. The patient was prescribed amoxicillin (+) AUGMENTIN, BENADRYL and TYLENOL. The patient was examined in the office on 08-MAY-2008 and the symptoms had improved. The patient had subsequently recovered. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a pharmacist via a company representative refers to a male patient of unknown age. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (dose, dose number, route of administration, injection site, lot number and expiration date were not provided). There were no concomitant medications reported. The pharmacist stated that the unspecified patient was "pulled over by the cops" for an unspecified reason "a couple days after receiving ZOSTAVAX", and upon pulling over, the cops noted that the "pupils would not dilate" in the patient's eyes (date unspecified). The outcome of pupillary reflex impaired was unknown at the time of the report. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
This spontaneous report was received from a physician via a company representative and refers to an unspecified number of patients of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in approximately June 2015 (reported as "this summer"), the patients were vaccinated with the second dose (of two) of VARIVAX (Merck) (dose and route of administration were not reported). On an unknown date in approximately 2015, the patients experienced injection site reaction, the injection site was red and swelling. The patients sought medical attention, they were in the physician's office. No treatment was given to them for the event. The outcomes of the events were reported as recovered on an unspecified date in approximately 2-15. The relatedness between the events and VARIVAX (Merck) was not provided. Additional information has been requested.
The injection sites are swollen, hot and red. The reactions occur after 28-30 hours. The flu and pneumococcal vaccines were given on the same arm on Wednesday 10/12. Patient took 1 Benadryl tab 25mg on Thursday night. She came in my pharmacy the next day, I instructed her to do ice pace and take Advil, ask to call back.
Developed a swollen tender lymph node in the right Supraclavicular area, no other symptoms noted. No treatment to date.
Woke up at 4 am with severe headache ,diaphoretic, and dry heaves.  I took 1 Tylenol and checked my blood pressure which was 179/123 at 4:26 am,  pressure dropped to 154/112 by 4:42 am and 148/106 by 5:55 am.  Blood pressure varies normally between 120/80 to 140/90 pain  and other symptoms subsided by 5 am
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 3 months old patient of unknown gender. On 06-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
Rt leg redden, warm to touch, no fever, did not itch. BENADRYL allergy children liquid.
Swollen, painful lymph nodes mostly in axilla; Swollen, painful lymph nodes mostly in axilla; Painful achy legs; Headache; Fatigue; Booster dose; Influenza vaccine was taken on the same date of suspect vaccine.; This is a spontaneous report from a contactable nurse, the patient. A 24-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 06Oct2021 at 12:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The medical history included hashimoto's, irritable bowel syndrome (IBS), polycystic ovarian syndrome (PCOS) and immunization. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within 4 weeks prior to the COVID-19 vaccine included hepatitis b vaccine (MANUFACTURER UNKNOWN) on 16Sep2021 and influenza vaccine (MANUFACTURER UNKNOWN) on 06Oct2021, both for immunization. The concomitant medications included omeprazole (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates and unknown if ongoing. The patient previously patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration on 30Dec2020 (at the age of 23-years-old) and  the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 22Jan2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. On 06Oct2021 at 15:15, the patient experienced swollen, painful lymph nodes mostly in axilla, painful achy legs, headache and fatigue. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen, painful lymph nodes mostly in axilla, painful achy legs, headache and fatigue were resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
little COVID vaccine killed my dad; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (little COVID vaccine killed my dad) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Company comment : This spontaneous case concerns an adult male patient of unknown age with no medical history reported, who died an unknown time after a dose of mRNA-1273.222. Information regarding clinical evaluation, diagnostic tests and autopsy reports has not been disclosed. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.   Reporter did not allow further contact; Reporter's Comments: This spontaneous case concerns an adult male patient of unknown age with no medical history reported, who died an unknown time after a dose of mRNA-1273.222. Information regarding clinical evaluation, diagnostic tests and autopsy reports has not been disclosed. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Swollen at the injection site; Arm was painful at the injection site; I couldn't lift my arm over my head; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't lift my arm over my head), NAUSEA (Nauseated), VACCINATION SITE SWELLING (Swollen at the injection site) and VACCINATION SITE PAIN (Arm was painful at the injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were reported.     On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't lift my arm over my head), NAUSEA (Nauseated) and VACCINATION SITE PAIN (Arm was painful at the injection site). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swollen at the injection site). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't lift my arm over my head), NAUSEA (Nauseated), VACCINATION SITE SWELLING (Swollen at the injection site) and VACCINATION SITE PAIN (Arm was painful at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2021-077863 (Patient Link).
Received Moderna booster on reported date after having initial vaccine schedule completed with Pfizer. Since receiving booster, extreme menstrual cramps and increased vaginal bleeding observed with this mentrual cycle. Also normal menstration duration is 5 days and so far on day 8. On day 8 small facial hives have appeared in the am as well as intense itching on injection arm.  Oral Loratadine 10mg take for itching and hives.
rashes at inner thighs up to the neck; hives at inner thighs up to the neck; patient reported major itching symptoms; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of RASH (rashes at inner thighs up to the neck), URTICARIA (hives at inner thighs up to the neck) and PRURITUS (patient reported major itching symptoms) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced RASH (rashes at inner thighs up to the neck), URTICARIA (hives at inner thighs up to the neck) and PRURITUS (patient reported major itching symptoms). At the time of the report, RASH (rashes at inner thighs up to the neck), URTICARIA (hives at inner thighs up to the neck) and PRURITUS (patient reported major itching symptoms) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment: Antihistamine medications as a corrective treatment.  Patient developed rashes and hives at inner thighs up to the neck, 5 days after the 1st shot. The patient felt better now. According to patient the rash was persisting for more than 3 and a half weeks
I woke up with extreme burning chest pain at 5:30 am on December 25, 2022.  Breathing was still normal, but the chest was hurting and the pain would not go away. Got driven to the Hospital and admitted into the ER.
Felt a little sinus congestion; Low grade fever of 99.3; Very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of SINUS CONGESTION (Felt a little sinus congestion), PYREXIA (Low grade fever of 99.3) and HEADACHE (Very bad headache) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced SINUS CONGESTION (Felt a little sinus congestion), PYREXIA (Low grade fever of 99.3) and HEADACHE (Very bad headache). At the time of the report, SINUS CONGESTION (Felt a little sinus congestion), PYREXIA (Low grade fever of 99.3) and HEADACHE (Very bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Body temperature: 99.3 (Inconclusive) Low grade fever 99.3.         No concomitant and treatment medications were reported.
There is a rash that has appeared on my left arm surrounding the injection site. It started to feel uncomfortable on Monday, March 8th, and then today it felt a  little bit itchy. When I looked in the mirror, I saw a red rash. The area feels warm to the touch, it doesn't feel painful, but uncomfortable. It is about the diameter of my thumb, albeit not a perfect circular shape.
patient's husband cal;led on 9/2/20 at 12pm to report that his wife experienced a high fever (no number was divulged) and shivering in the middle of the night that was resolved with 2 ibuprofen otc
after waiting 15 minutes in office and being discharged without any issues, the patient returned to the office within 10 minutes with mild swelling of the right middle finger.  Pt also stated that is was tingling.  Pt also had a red mark on the inside of his elbow.  After watching patient for another 10 minutes he stated that his right arm was beginning to tingle and feel numb in some places.  Vital signs were stable.  Pt was given 50mg of Benadryl by  mouth.   After another 10 minutes, it was noted that pt  had a small hive on the right middle finger and that he was feeling a little "fuzzy headed".  Pt was rechecked after another 15 minutes and was noted to be feeling just tired, likely from the benadryl.  He no longer felt 'fussy headed" and the hive which was still present was no longer red and was beginning to fade away.  Pt remained in office for another 10 minutes or so.  Patient's vitals were stable and he seemed to no longer be reacting so he was discharged home.
This spontaneous report as received from a Healthcare worker refers to unknown number of patients of unknown age and gender. Approximately in 2013 the patients were vaccinated with ROTATEQ (lot # and expiration date unspecified) (dose, route and anatomical location unspecified). The Healthcare worker reported that an unknown number of patients received ROTATEQ that were exposed to temperatures of 53F for 68 hours beginning on 29-MAR-2013, and then exposed to temperatures of 52F for 68 hours beginning on 12-APR-2013. All doses were administered after 29-MAR-2013. No adverse effect reported. This is one of two reports from the same source (MARRS 1306USA001991). Additional information has been requested.
AT THE INJECTION SITE - PATIENT EXPERIENCED ITCHING, REDNESS AND SWELLING, FEVER AT THE SITE, HARDNESS AND PAIN.
Neck pain, numbness of the face right side, asymmetry on the right side of the face, and face pain and on the mandibula
the first evening I took sinus medication because I had been having sinus issues since having Covid.  I think I had a fever. The sinus meds had acetaminophen so it was under control. I had chills. I have fatigue. I also have sleep apnea so my c-pap machine helped a little. I have gradually started feeling better. Injection site was red and huge swollen. it is fine now.
Reported pain and fever that occurred day after vaccination. Fever resolved by 1/20/2016 when seen by provider.
Blood pressure was 195/96; Shortness of breath; Confusion; Weakness; Diarrhea; Speech was slurred; Additional rashes appeared; Chills; Tired; Headache; Joint pain; rashes that started to appear, itching, discomfort; Discomfort; Slept most of the night; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (Blood pressure was 195/96) and DYSPNOEA (Shortness of breath) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced SOMNOLENCE (Slept most of the night). On 15-Mar-2021, the patient experienced RASH PRURITIC (rashes that started to appear, itching, discomfort), DISCOMFORT (Discomfort) and ARTHRALGIA (Joint pain). On 16-Mar-2021, the patient experienced HYPERTENSION (Blood pressure was 195/96) (seriousness criterion hospitalization), DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization), CONFUSIONAL STATE (Confusion), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), DYSARTHRIA (Speech was slurred), RASH (Additional rashes appeared), CHILLS (Chills), FATIGUE (Tired) and HEADACHE (Headache). The patient was hospitalized from 16-Mar-2021 to 17-Mar-2021 due to DYSPNOEA and HYPERTENSION. The patient was treated with FLUTICASONE PROPIONATE (FLONAZE) (intravenous) at an unspecified dose and frequency; FAMOTIDINE at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. On 13-Mar-2021, SOMNOLENCE (Slept most of the night) had resolved. On 16-Mar-2021, HYPERTENSION (Blood pressure was 195/96), CONFUSIONAL STATE (Confusion) and DYSARTHRIA (Speech was slurred) had resolved. On 17-Mar-2021, RASH PRURITIC (rashes that started to appear, itching, discomfort), DIARRHOEA (Diarrhea) and RASH (Additional rashes appeared) had resolved. At the time of the report, DYSPNOEA (Shortness of breath) had not resolved and DISCOMFORT (Discomfort), ASTHENIA (Weakness), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: 195/96 (High) units not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.
Father reports pts arm was swollen 5-6 days 3-4 diameter area, very tender, was not able to sleep on arm.