chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Well my arm at the injection site is about 5 times in size/ her arm is swollen 2-3 times the size since she received the vaccine on Sunday; My arm at the injection site is about 5 times in size; it's huge and hot to touch, it's red also; My arm at the injection site is about 5 times in size; it's huge and hot to touch, it's red also; the lymph nodes under arm are swollen; has been running fever with 100.5 being the highest that it has gotten.; redness; This is a spontaneous report received via Pfizer-sponsored Program Pfizer First Connect from a contactable nurse (the patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient received 1st dose of Covid vaccine and was experiencing some side effects such as her arm was swollen 2-3 times the size since she received the vaccine on Sunday, the Lymph nodes under arm are swollen and she had been running fever with 100.5 being the highest that it has gotten. Nurse stated, I was trying to speak with someone regarding the vaccine, I received on Friday, I mean on Sunday. I know that it specified that you could have redness, swelling, fever and all of that stuff which I've had all of that and the swelling in the lymph node and stuff, well my arm at the injection site is about 5 times in size, when confirmed if nurse wanted to know if it was normal or not, nurse stated, yeah it was huge and it was hot to touch, and it's red also. The patient underwent lab tests and procedures which included fever (body temperature): 100.5 on an unspecified date. The outcome of all the events was unknown.  Information on the Lot/Batch number has been requested.  Follow-up attempts completed. No further information expected.
Medication leaked out during administration/leaked down the patients arm; Medication leaked out during administration/leaked down the patients arm; Medication leaked out during administration/leaked down the patients arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 65-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number A7TN9, expiry date 22-OCT-2024) for prophylaxis.   On 20-SEP-2023, the patient received Arexvy. On 20-SEP-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: Medication leaked out during administration/leaked down the patients arm), inadvertent exposure to vaccine (Verbatim: Medication leaked out during administration/leaked down the patients arm) and exposure via skin contact (Verbatim: Medication leaked out during administration/leaked down the patients arm).The outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 21-SEP-2023 The reporter reported that Arexvy leaked out between the needle hub and the needle when she pressed the plunger to administer the vaccine and the reporter noted the vaccine leaked down the patient's arm, which led to incomplete dose administered, inadvertent exposure to the vaccine and exposure via skin contact. No other details were provided. The reporter consented to follow up.
6/1/32022-Presents to ED, SOB, fatigue, decreased appetite, nausea and diarrhea. Pt on Augmentn for cat bite wound. Afebrile, On 2L NC  94% spo2.. Covid + test. CRP. Ordered Decadron, ceftriaxone and doxy. CXR-pulmonary edema.  Admit CHF exacerbation Covid . 6/14/2022- Started on remdesivir and barictininb.  6/16/2022- Weaned down to RA, spo2 95%. 6/21/2022-Completed remdesivir , d/c steroids and baricitinib as no further resp symptoms at day 5. VSS afebrile.  6/24/2022- D/C to SNF .
Erythematous, indurated are 4.5 x 4.5" on R arm with no tenderness.  No fluctuence.
Patient reports that after receiving shot of gardasil abd menectra on 02/25/2009 she became very sleepy but not lethargic and experienced a severe headache. She didn't report this because she didn't know if it was from shots or if she was just feeling bad. Patient opted to receive second dose of Gardasil on 05/13/2009. Patient waited in lobby for 15 minutes after receiving injection per protocol. Patient reported no adverse reactions during that time. Patient was asked bymyself how she felt every 5 minutes for 15 minutes. Mom called clinic today at 16:30pm to report that patient didnt report it yesterday but 10 minutes after receiving injection she started feeling extremely sleepy and experiencing a severe headache. Patient didn't want me to know for fear that she would have to stay at clinic longer. Patient currently not feeling tired anymore but still experiencing headache. I instructed patients mother to monitor her and if symptoms worsened to seek immediate attention at the ER. Patient is treating headache with Tylenol 500mg OTC. Patient and mother voiced understanding for treatment.
TC from client on 7/19/11 who states received vaccine on 7/7/11 and sight of injection just painful the next few days.  Then on 7/17/11 noted area around site reddened and swollen in an area 4 inches by 1 1/2 inches with some itching and burning also.  Denies fever.  I discussed symptoms to report to MD and she states she has an appt for 7/21/11 to be seen at MD office.  TC to patient again on 7/22/11 and she states that she was diagnosed with delayed hypersensitivity or cellulitis and is now taking Keflex.  Patient states the arm feeling worse today and she has again waiting on a call back from the MD office she called today.
Patient's physician reported this adverse event by phone to Medical Center administration on 4/13/2021.  Per the physician, the patient received his 2nd Pfizer COVID19 vaccination dose on Friday 4/9/2021 at the drive through vaccination clinic.  On Saturday 4/10/2021 the patient told to his wife that he felt ill, continuing through Sunday.  On Sunday, 4/11/2021, at his home, the patient told his wife that he felt ill and went to sleep.  The patients wife found him not breathing, called 911 and started CPR.  The patient was pronounced deceased at his home and was not transported to hospital.
2 days after the vaccine, the patient was rushed to ED due to the onset of altered mental status, bilateral extremities weakness and unable to speak, and concern for right facial droop.  He was initially stroke alerted but no findings of any acute ischemic infarction, acute intracerebral hemorrhage was found. cTA w/out LVO, CTP unremarkable.  At baseline, patient is chronic dysarthria and left facial weakness following his TBI approximately 15 years ago. He reports his last seizure was approximately around the same time.  He endorses adherence with home upper AND carbamazepine. On the day of presentation, he reported that he had received vaccination for COVID-19 and had briefly been subjectively febrile and thinks this may have provoked his seizure event.  His last imaging within record of MRI brain was 2017. Repeat MRI performed during this hospital stay showed numerous cerebral cavernous malformations, including new small cavernomas supra and infratentorially and subacute blood products within the left insular lesion. This is believed to not be new with a provoking factor for his seizure.
After waiting the 15 minute observation period the patient, informed that her throat was feeling itchy. The provider, DNP, was notified and noticed that the patient was also developing hives on her chest. The provider then ordered 125mg of Solu-Medrol and 50mg of Diphenhydramine to be administered to the patient via injection. The provider also okayed water to be given to the patient. Patient was then observed for an additional 20 minutes.
dose 1 month apart; This case was reported by a pharmacist via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX).   On 12th July 2021, the patient received the 2nd dose of Shingrix. On 12th July 2021, unknown after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist asked for further instructions for a patient who received a Shingrix dose 1 month apart, which led to shortening of the vaccine schedule. The reporter agreed for follow up.
Information has been received from a 66 year old female consumer with no known allergies with a thyroid disorder who on 28-MAR- 2007 was vaccinated with a dose of Zostavax. Concomitant therapy included levothyroxine Na (SYNTHROID) and esomeprazole magnesium (NEXIUM). On 28-MAR-2007 the patient experienced muscle pain throughout her body. At the time of the report, the patient had not recovered. Unspecified medial attention was sought. No product quality complaint involved. No further information is available.
Headache, Fever, CoughWheeze, NauseaVomiting, c/o fatigue,chills. Told to follow up with primary care physician if problems persist.  Narrative:
This spontaneous report was received from a health care worker, concerning an unspecified number of patients. The patients pertinent medical history and drug reactions/allergies were not provided. On an unspecified date, the patients received one dose of RECOMBIVAX HB (dose, route, lot number and expiration date were not provided). Other suspect therapies included a dose of GARDASIL (dose, route, lot number and expiration date were not provided), and a dose of (merck) VARIVAX (dose, route, lot number and expiration date were not provided). Concomitant medications were not provided. The reporter stated that an unspecified number of patients received doses of RECOMBIVAX HB, GARDASIL, and (merck) VARIVAX, that were exposed to unsupported temperature excursions. No adverse effects were reported. Additional information has been requested.
Tested positive for covid a week later after his first shot; Tested positive for covid a week later after his first shot; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in the left arm on 28Dec2020 at 12:00 PM in a hospital at a single dose as a COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient had no known allergies but had other medical history (unspecified). The patient did not receive any other vaccine within four weeks prior to the COVID vaccine, had other medications in two weeks (unspecified), and was not diagnosed with COVID-19 prior to the vaccination. The patient tested positive for COVID a week later after his first shot. The test used was via nasal swab on 04Jan2021. The patient did not receive any treatment for the events. Outcome of the events was reported as recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).  Information on the lot/batch number has been requested.
Blood sugars out of normal  range. Bed time reading 150 points above normal, to 295. Morning readings up 50 points. Noon time readings up 100 points, dinner time readings up  50 points.
Swelling, rash, heat at site of injection getting larger 48 hours after. Headache.
Pt had hx of diabetes, elevated BP & obesity; devel GBS approx 2 wks p/vax; devel pneumonia & was put on ventilater;
No adverse events. Dosing error, patient given 0.25mL of bivalent booster instead of the recommended 0.5mL
Called and stated left arm really sore. She can move the arm. It is just sore. She took Tylenol/Advil with no relief. I told her to continue with medication and to use hot or cold pack as per relief. If no relief, call doctor.
Petechial rash and itching initially around site of injection, and then spread to both arms, and now is present on arms, lower back, and abdomen.
This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (Hard spot) and RASH (Slight rash at that point) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20H) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Feb-2021, the patient experienced INDURATION (Hard spot) and RASH (Slight rash at that point). At the time of the report, INDURATION (Hard spot) outcome was unknown and RASH (Slight rash at that point) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 58-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No concomitant drug was reported. Patient ID was reported as Unknown It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Reportedly, the patient was eligible for COVID-19 vaccine. No treatment drug was reported.
Patient developed recurrent vomiting and was ultimately diagnosed with intussusception requiring successful operative reduction after failed fluoroscopy enema.
Tested positive for COVID after having received the vaccine; Tested positive for COVID after having received the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 2 patients. This is 1st of 2 reports. A 7-decade-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EJ1685, expiration date: Mar2021), via an unspecified route of administration on 18Dec2020 at left deltoid, at 0.3 mL, single for covid-19 immunization. Medical history included ongoing diabetic. Concomitant medication included insulin for diabetic; pioglitazone hydrochloride (ACTOS) for diabetic and all ongoing. The patient received the vaccine on 18Dec2020 and then less than a week later, on 23Dec2020 was positive for COVID. The reporter said that they had been vaccinating people at their work. The reporter had vaccinated two people now who within about a week after, they tested positive for COVID. The patient was exposed to COVID outside of work. This patient was a healthcare worker (Doctor) in his 60's, weight within normal limits. The reported stated that obviously this person was exposed prior to getting the vaccine and was not symptomatic. But she needed to know, should she stick with the 21 day time period for the second dose or wait 90 days. The patient described COVID as the flu with an attitude. He was staying home and resting. The reporter did not think, with either of these patients that them getting COVID had anything to do with the vaccine. She thought it was a coincidence and they were obviously exposed prior to receiving the vaccine. The event was assessed as non-serious, and unrelated to vaccine by reporter. The outcome of the events was not recovered.; Sender's Comments: There is not a reasonable possibility that event "tested positive for COVID" is related to BNT162B2 vaccine.  Patient most likely was exposed to SARS-CoV-2 virus prior vaccination.,Linked Report(s) : US-PFIZER INC-2021001199 Same drug and events, different patient
slight increase in itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (slight increase in itching) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease (Slight increase in hand tremors and balance condition) since 20-Jun-2017, Restless leg syndrome, High cholesterol, Hypothyroidism (low thyroid) and GERD. Concomitant products included PANTOPRAZOLE for GERD, SIMVASTATIN for High cholesterol, LEVOTHYROXINE for Hypothyroidism, RASAGILINE from 20-Jun-2017 to an unknown date for Parkinson's disease, ROPINIROLE for Restless leg syndrome.   On 20-Jan-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (slight increase in itching). At the time of the report, PRURITUS (slight increase in itching) had resolved.      Treatment information not provided for 2nd dose.   This case was linked to MOD-2021-010087 (Patient Link).
My daughter experienced immediate nerve pain at the site, L deltoid; followed by radiation to her fingers.  Then, she complained of extreme muscle pains, all over; itching and shortness of breath with formation of mucus in her chest.  She has interstitial lung disease and is well aware of what mucus-filling in her chest (lungs) feels like.  She also had headache and coughing and this necessitated using Benadryl 50mg, her Xopenex rescue inhaler at the site; followed by contacting of her pulmonologist for future treatment and instructions.
Lg local reaction LA, no fever.  Advised ice/ibuprofen/Benadryl.
PT WAS GIVEN A VACCINE THAT EXPIRED ON FEBUARY 12TH, IT WAS STORED IN THE FRIDGE AND NOT USED UNTIL THIS POINT.
Information has been received from a 71 year old male patient with hay fever, pollen, dust and mold allergy and s history of back surgery "about ten or fifteen-years-ago", in approximately 2002 who "about three years ago", in approximately 2009 was vaccinated SC with a dose of ZOSTAVAX (Merck) (lot number not reported), 0.5ml. Concomitant therapy included clonazepam, ZOLOFT and unspecified heartburn medication. The patient mentioned that "about one month ago", in approximately April 2012 he experienced or came down with shingles while visiting his brother in other country. The patient had sought unspecified medical attention and was given valacyclovir hydrochloride. The patient had done annual check-ups and tests. At the time of the report, the patient was not recovered. Follow-up information has been received via FAX concerning the patient who was vaccinated with 0.5 ml ZOSTAVAX (lot# 664029/0196Y) at left arm on 13-JUL-2009. As reported the patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. The patient developed shingles on 04-MAY-2012, 3 years after vaccine, no rash occurred at the site of injection post-vaccination and rash was not cultured. Also no culture done at health medical. Additional information has been requested.
AE: Red itching rash visible on arms, "woozy feeling", shortness of breath. Treatment: Auvi-q.
Administered expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) in a 52-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. HCP administer expired vaccine to patients, after the manufacture date of expiration and wanted an assessments on the case.  Number of doses/vials:173 doses Date the vial was initially stored in the refrigerator was unknown. Date(s) of administration of vaccine: 08-Apr-2022, 12-Apr-2022 and 13-Apr-2022.  No treatment medications were provided. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information
COVID-19; COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 at 11:00 as dose 1, single (Lot number: EN6203), in left arm, on 22Mar2021 at 11:00 as dose 2, single (Lot number: ER8727), in left arm and on 08Dec2021 at 13:00 as dose 3 (booster), single (Lot number: 33038D) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN oral, start date: 28Feb2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result, notes: COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received drug Paxlovid oral from May2022 as COVID 19 treatment.
Had symptoms of fast pulse, light-headedness, heat intolerance.  Eventually had blood work done and found abnormally low TSH, higher than normal T4 and positive for TgAB, despite never having any problems with thyroid in the past or really any abnormal blood test results of any kind.  Thyroid tests continued to be abnormal for about three months, and then in September were normal again.
Pt reportedly died in 1983 following the administration of Tri-Immunol; lot# was not recorded; No further clinical details available;