chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called office 10 AM 10/08/2003 to state site where she received flu shot was very red and swollen states not painful but did concern her.  Area is raised, slightly red, approximately 2.5 inches wide by 1.5 inches tall.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from 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 08Feb2021 at 09:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 25Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 26Apr2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypoglycemia" (unspecified if ongoing); "digestive issues" (unspecified if ongoing); "weight loss from two surgeries" (unspecified if ongoing), notes: weight loss from two surgeries; "oysters" (unspecified if ongoing); "Mussels" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE; LORAZEPAM; FLONASE ALLERGY RELIEF. Past drug history included: Lactose, reaction(s): "Allergy"; Gluten sensentivity, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (22Jun2022) I had a temperature, notes: I had a temperature from 22Jun until 05Jul; SARS-CoV-2 test: (unspecified date) Unknown reusult, notes: Covid-19 treatment; Weight decreased: (unspecified date) 6 lbs, notes: I lost an additional 6 pounds. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Anti -viral details: Product - COVID 19 Treatment, Brand - Paxlovid, Treatment start date - 22Jun2022, Treatment stop date - 27Jun2022, Indication - Treatment of COVID -19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had rapid heartbeat for about 2 weeks. Them I had an irregular heartbeat for about 2 months, so I went to the doctor. The heartbeats went like this: boom...boom...boom. BOOM.  I have no history of heart problems at all. My Blood pressure is usually 110/70, within normal range.
This spontaneous report as received from a physician refers to a 4 year old patient of unknown gender. No information provided regarding concurrent conditions and medical history. On 14-MAY-2014 the patient was vaccinated with PROQUAD and VARIVAX (dose, route, lot number and expiration date not reported) on the same day. No adverse effect reported. No product quality complaint reported. Follow up information was receipt regarding the age of the patient reported as 12 months old which was previously reported as 4 years old. Additional information has been requested.
Red, swollen, hot to touch at site of injection started about 24 hours after injection. Still red, swollen, hot to touch 48 hours later. Also experiencing body aches, headache, nausea, and itchy throat for past 48 hours.
Three days after Hep B vaccine #2 (1st vaccine 1 year earlier) fever of 104, headache, seizure. Diagnosed with viral meningo-encephalitis. The discharge summary states encephalopathy.
After waiting the post vaccine required 15 minutes, I leisurely left the site and decided to go grab lunch. I picked up my order at 2:45, so my guess is I took my first bite around 2:50. That's when I noticed I couldn't swallow. I began to choke since I couldn't swallow my food. I had some water, relaxed myself, and tried to keep eating. It was hard to do. Now that it's 5:30, my throat still feels slightly closed.
Patient experienced muscle tenderness on her upper arm. Also pain on that area followed by fever for a couple days.
This spontaneous consumer report (initial receipt 24-Oct-2013) concerns a 64 year old male patient with a medical history of diabetes. Concomitant medications included atenolol, fluoxetine, gabapentin, simvastatin and metformin. The patient had no drug reactions/allergies. On an unspecified date 4 weeks ago, the patient received AFLURIA (batch unspecified). After receiving AFLURIA, the patient developed Bell's Palsy. The patient sought medical attention through seeing his physician. CAT (computerised axial tomography) scan and MRI (magnetic resonance imaging) were negative for brain damage. No treatment was given for the adverse event. The event outcome was not recovered.
Sore arm; "Crawling sensation" in her left arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 374LB, expiry date 28th June 2022) for prophylaxis.   On 15th July 2020, the patient received Boostrix (intramuscular) .5 ml. On 16th July 2020, 1 days after receiving Boostrix, the patient experienced pain in arm and formication. On an unknown date, the outcome of the pain in arm and formication were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and formication to be related to Boostrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient developed sore arm and the arm soreness continued but was less. The patient was complaining of a crawling sensation in her left arm. The patient stated that all might be in head. The reporter did not consent to follow up.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-FEB-2007, 20-FEB-2010 and 02-MAY-2018, the patient was vaccinated with doses of M-M-R II, subcutaneously (dose, anatomical place of vaccination, lot# and expiration date were not provided), for prophylaxis. No known adverse effects.
No adverse event; Vaccine was expired at the time of administration/6 doses administered on 07-May-2022 with a published expiration date of 25-mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired at the time of administration/6 doses administered on 07-May-2022 with a published expiration date of 25-mar-2022) and NO ADVERSE EVENT (No adverse event) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2022 at 2:25 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-May-2022 at 2:25 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired at the time of administration/6 doses administered on 07-May-2022 with a published expiration date of 25-mar-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired at the time of administration/6 doses administered on 07-May-2022 with a published expiration date of 25-mar-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was expired at the time of administration/6 doses administered on 07-May-2022 with a published expiration date of 25-mar-2022).    Patient's race was reported. No concomitant medications were reported. The event did not cause the patient to seek medical care. The patient did not have any adverse effects from this vaccine.  The dates of the first two doses was unknown. It was unknown if any other vaccines were given in the 4 weeks prior to COVID-19 vaccine. It was reported that determine course of action when COVID vaccine given past expiration date. 6 doses administered on 07 May 2022 from lot number 033H21A with a published expiration date of 25 Mar 2022. Health care professional stated that they were the 1st boosters.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-714990 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714990:Patient S-E
Initial report received in the United States from the patient's parent on 03 August 2007. A five-year-old female patient with a history of asthma and allergies to beef, pork, eggs (mild) and dairy products experienced severe coughing, congestion and neck and facial swelling 10-15 minutes after she had received a left thigh injection of Daptacel, lot number C2657AA, and a left thigh injection of IPOL, lot number AVB20873. The routes of administration were not reported and the lot number reported for IPOL is not valid. The patient has a history of asthma and was receiving the medication Flovent until June 2007. No other concomitant medications were reported. The patient's parent denied any previous reactions following vaccination. On 01 August 2007, 10-15 minutes after she had received the vaccine, the patient experienced severe coughing, congestion, and neck and facial swelling. The patient was treated with oral Benadryl and epinephrine and her symptoms improved. She was instructed to continue taking epinephrine for three days. The reporter provided information relating to the patient's allergist and stated that this patient had recovered from this event.
freeze; Dull Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (freeze), HEADACHE (Dull Headache) and FATIGUE (Tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASA for an unknown indication.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced FEELING COLD (freeze), HEADACHE (Dull Headache) and FATIGUE (Tired). On 17-Apr-2021, HEADACHE (Dull Headache) had resolved. At the time of the report, FEELING COLD (freeze) and FATIGUE (Tired) outcome was unknown.            Patient was taking unspecififed blood pressure medication Treatment medications were not mentioned   This case was linked to MOD-2021-053361 (Patient Link).
Information has been received from a pharmacist concerning a 72 year old female with penicillin allergy who on 19-JAN-2009 was vaccinated with ZOSTAVAX (Oka/Merck) (lot number and site not reported) ).65 ml subcutaneous. Concomitant therapy included levothyroxine, hydrochlorothiazide (+) triamterene and ginkgo biloba. On approximately 2-FEB-2009, the patient developed a rash that came and went. At separate times the rash was located on the patient's torso and upper thighs. Additional information has been requested. Follow-up information was received from the pharmacist concerning the female patient who on 19-JAN-2009 was vaccinated with her first dose of ZOSTAVAX (Oka/merck) (lot number 662757/1622XX) into her deltoid. On an unspecified date the patient developed a miner rash. The outcome was unknown. There was no illness at time of vaccination. Additional information has been requested.
Pt with special needs arm being held by family/POA member, upon sticking patient, patient rapidly moved arm and the needle withdrew. No vaccination was administered at this time. New vaccine was obtained and given.
Morbidly obese ( Wt (!) 185.5 kg (409 lb) | BMI 64.06 kg/m² 12/2020) patient with PMH paroxysmal atrial fibrillation, HTN, and other comorbidities (documented allergies:  aspirin, losartan, and shellfish) presented for dose 2 of COVID-19 Moderna vaccine on 4/16.  COVID-19 Moderna vaccine (LOT # 044B21A) administered IM to patient's right deltoid by Staff at Clinic ~ 1647.  This clinic has not been routinely using syringes with the 1.5 inch needles recommended for larger patients to prepare vaccinations.  Patient returned to clinic on 4/21 noting she felt vaccine had been given in subcutaneous tissue instead of deltoid.  Right arm injection site noted to be red with some induration and and "appears to be down Additional information for Item 18: Right arm injection site noted to be red with some induration and and "appears to be down and to side of deltoid".  Patient with questions regarding titers and whether she should receive another dose due to possible incorrect administration technique.  Clinic leadership aware and ID contacted to address patient's concerns.  Of note, Moderna COVID vaccine #1 given on 3/19/21 (LOT # 038A21A, IM LD).  oF NOTE, UPDATED WEIGHT NOT AVAILABLE.
4/16/10 Received VARICELLA shot. That night got red and hot to touch with knot.  Spot 2 1/2 by 3 1/2 inches long.  NC fever.
He felt lightheaded, laid back in car, head tilted to the side his body clenched up, arm curled up and wrist and hands curled up and legs stuck straight out stiff like, then body began shaking, he was non responsive to me shouting at him to 10 sec. He does not remember it happening.
Developed a rash down the arm with hives and itching. Developed chest pain and shortness of breath. This was diagnosed as an allergic reaction.
Diffuse urticaria starting 1 week after vaccine, that has since lasted 2 days
Headache, right retroocular pain, exacerbation of rosacea  Tx. acetaminophen  Duration: 3 hours
Felt really sick for day and half; Chills; Swelling at the sit of injection upto end of their biceps; received a 3rd dose which was full dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt really sick for day and half), CHILLS (Chills), VACCINATION SITE SWELLING (Swelling at the sit of injection upto end of their biceps) and ACCIDENTAL OVERDOSE (received a 3rd dose which was full dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2021, the patient received dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (received a 3rd dose which was full dose). On an unknown date, the patient experienced ILLNESS (Felt really sick for day and half), CHILLS (Chills) and VACCINATION SITE SWELLING (Swelling at the sit of injection upto end of their biceps). On 10-Aug-2021, ACCIDENTAL OVERDOSE (received a 3rd dose which was full dose) had resolved. At the time of the report, ILLNESS (Felt really sick for day and half) and CHILLS (Chills) was resolving and VACCINATION SITE SWELLING (Swelling at the sit of injection upto end of their biceps) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported. Patient stated that they experienced chills, felt really sick for day and half, by Sunday afternoon they felt better.
This spontaneous report as received from a registered pharmacist refers to unspecified number of patients. On an unspecified dates the patients were vaccinated with ZOSTAVAX (dose, route and lot# not reported). It was reported that a few days later the patients experienced pain at the injection site. At the time of reporting, the outcome of the event was unknown. It was unknown if the patients sought medical attention. This is one of the several reports from the same reporter. Additional information has been requested.
Received vaccine on 6/21/17 had L hand and arm numbness on 7/7/17 seen doctor on 7/7/17 had noticeable L hand weakness compared to Rt.
This is the message I sent to my PCP; 1/22/2021; I had COVID (027L20A) vaccine on 1/13 (Wed) because I am a health care worker. Right after the vaccine, I was fine. But then the arm got very itchy started/noticed on Monday (i.e. 6 days later) and became larger by Wednesday (1/20). The itchy/swelling/redness large area is still there (i.e., haven't disappeared and haven't become smaller). Is this also a normal side effect? Please see the attached files. On the website, that kind of side effect happens within a few days after the vaccination. But in my case, 6 days later. So I was wonder and worried. It's not urgent, I hope, but I wanted to report this (as recommended by CDC guideline). Please let me know. Thank you. They said: At this time, I would suggest to draw a line around the rash to see if it grows bigger or smaller. If it grows bigger after 1 or 2 more days, send us a message again or give us a call back. To reduce pain and discomfort where you got the shot: Apply a clean, cool, wet washcloth over the area. Use or exercise your arm. Consider Over-the-counter medicine such as Ibuprofen or Tylenol. To reduce discomfort from fever: Drink plenty of fluids. Dress lightly. It is still itchy.  The redness area (about 11cm x 10cm oval-like) is still growing, I think, but swelling is getting better. I signed up app, but I haven't received the text message yet to report this.
3 days later, cellulitis developed on left arm, treated with IV antibiotics and followed by oral antibiotics.
LOSS OF TASTE (NO TASTE FOR COFFEE); FUNNY OR ROTTEN SMELL; SORES ON BOTH OUTER LIPS; LEAD TASTE IN MOUTH; SORES INSIDE MOUTH; SORES ON OUTSIDE OF MOUTH; NUMBNESS IN MOUTH; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. 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 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-MAY-2021, the patient experienced loss of taste (no taste for coffee). On 15-MAY-2021, the patient experienced funny or rotten smell. On 15-MAY-2021, the patient experienced sores on both outer lips. On 15-MAY-2021, the patient experienced lead taste in mouth. On 15-MAY-2021, the patient experienced sores inside mouth. On 15-MAY-2021, the patient experienced sores on outside of mouth. On 15-MAY-2021, the patient experienced numbness in mouth. Treatment medications (dates unspecified) included: ethanol/thymol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of taste (no taste for coffee), funny or rotten smell, sores on both outer lips, lead taste in mouth, sores inside mouth, numbness in mouth, and sores on outside of mouth. This report was non-serious.
Pt complain after getting injection arm continued to be extremely sore and on 9/8 was unable to sleep b/c of pain radiating to armpit and fingers numb. Pt offered to f/up with MD. Pt decide to take Ibuprofen and see.
PATIENT STATES THAT 10-12 DAYS AFTER THE FIRST INJECTION THAT SHE NOTED REDNESS/PINK, ITCHING, AND PAIN AT THE INJECTION SITE. SHE WAS SEEN BY PCP AND TREATED WITH OTC BENADRYL AND CORTISONE TOPICALLY.  THE ISSUES HAVE RESOLVED AND PATIENT IS IN THE CLINIC TODAY FOR HER SECOND COVID VACCINE.
Pain at inj site, tenderness, itching, & redness on first night. Then swelling into a big blister at the area Saturday. Got worse on Sun-Mon but better Tuesday AM. Still painful but blister is smaller.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 14-Feb-2021 to 01-Apr-2021 due to COVID-19. On 01-Apr-2021, COVID-19 (COVID-19) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      Patient received Lipitor and "some blood pressure medication" as concomitants.  The patient received the Plasma Therapy as a treatment. Patient still in pretty bad shape, patient wants to know she need to receive second dose or not.  Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the event is assessed as unlikely related to mRNA-1273.
Patient felt anxious after receiving vaccine. no respiratory distress, no itching, no scrathy throat. Patient brought to medical area. felt reassured. Almost immediately felt better. Stated she just felt nervous but feels normal now.
unable to use arm,  touch sensitivity to entire arm, rash at injection site for 2 days, fatigue, malaise, headaches, nausea, ulcers on tongue and inside mouth, joint pain and unable to use hands
This spontaneous report was received from a healthcare worker refers to a multiple unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients received improperly stored doses of GARDASIL (lot # K008931, exp. 04-MAR-2017, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information is not expected, no contact details were provided.
started with red rash (looked like mosquito bites) on (L) arm 2 days after received shot. Spread to (R) arm, to abdomen then to back and (L) leg. Saw MD for different issue & addressed rash. MD recommended HYDROCORTISONE cream & BENADRYL as needed. Rash started lessening on 10/3/09.
pt recv vax 9APR96 & 21APR96 pt devel rash on face & mild coryza;22MAR96 rash had worsened & pt exp itching & enlarged tonsils;pt exp mild congestion & a fever of 99.3;also mild hand pain from 18MAR96 through 26MAR96;dx probable measles
patient received zostavax vaccine on 10/4/07. She reported 2 days later that the site of injection was red and swollen.  She came into the pharmacy on 10/10/07 and reported that the swelling had gone down, but that the area was still red.  she reported a "knot" at the injection site.